(30 days)
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile
The provided document describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR. This is not an AI/ML device, but a reprocessed physical sensor. Therefore, many of the typical acceptance criteria and study components for an AI/ML device (like an algorithm's performance, human reader improvement, expert consensus for ground truth on images, training sets, etc.) are not applicable here.
Instead, the study focuses on demonstrating substantial equivalence to an existing predicate device by showing that the reprocessed sensor meets performance specifications and safety standards similar to a new device. The "ground truth" here is the actual arterial oxygen saturation measured by a co-oximeter, and the "device performance" refers to the accuracy of the SpO2 sensor against this gold standard.
Here's an attempt to extract and reframe the information based on the prompt's requirements, noting where AI/ML specific criteria do not apply:
Device: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
Device Type: Reprocessed pulse oximeter sensor (physical hardware, not an AI/ML algorithm)
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this device, as a pulse oximeter, is its accuracy in measuring SpO2. This is evaluated against an established standard (ISO 80601-2-61:2011).
| Acceptance Criteria (SpO2 Accuracy) | Reported Device Performance (Medline ReNewal MAXNAR) |
|---|---|
| Accuracy (Arms) for 70% - 100% SpO2 (per ISO 80601-2-61:2011 and FDA guidance) | Passed the Arms specification of 3% |
| Target Accuracy: ±3 digits in adults for 70-100% SpO2 range | Achieved an accuracy of 2% for 70% - 100% SpO2 |
| Pulse Rate Accuracy: 20-250 bpm ±3 digits | 20-250 bpm ±3 digits (Same as predicate) |
Note: "Arms" refers to the "Accuracy Root Mean Square" deviation, which is a statistical measure of accuracy for pulse oximeters.
Study Details
-
Sample Size and Data Provenance:
- Test Set Sample Size: 10 healthy adult volunteer subjects.
- Data Provenance: The study was conducted in a laboratory setting on healthy volunteers. The exact country of origin is not specified, but the context implies it's within the US, given the FDA submission. It was a prospective clinical trial.
- Subject Demographics: Ages 25 to 36 years; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4.
-
Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable in the typical AI/ML sense where human experts label images.
- The ground truth for SpO2 was established invasively using a co-oximeter (arterial blood gas analysis), which is the gold standard for measuring arterial oxygen saturation. This does not involve human expert interpretation of images. The study followed "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections."
-
Adjudication Method for the Test Set:
- Not applicable. This study is a direct comparison of the device reading against an objective, invasive gold standard (co-oximetry), not an interpretation that requires adjudication by multiple experts.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is relevant for AI/ML systems that assist human interpretation of medical images. This device is a sensor that directly measures a physiological parameter. The study focuses on the sensor's accuracy, not its impact on human reader performance.
-
Standalone (Algorithm Only) Performance:
- Yes, but framed differently. This is a hardware device, not an algorithm. The "standalone performance" is the accuracy of the reprocessed sensor itself (Model MAXNAR) in measuring SpO2 and pulse rate against the co-oximeter standard, without further human interpretation other than reading the display. The reported performance of 2% SpO2 accuracy is this standalone performance.
-
Type of Ground Truth Used:
- Outcomes Data/Physiological Measurement (Invasive Gold Standard): Arterial oxygen saturation (SpO2) measurements obtained via co-oximetry on arterial blood samples from healthy volunteers. This is considered the true physiological value.
-
Sample Size for the Training Set:
- Not applicable. This isn't an AI/ML algorithm that requires a training set. The "training" for a reprocessed device involves the manufacturing and reprocessing procedures themselves, ensuring they meet the original equipment manufacturer's specifications and performance.
-
How Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set in the AI/ML context. The closest analogy would be the validation of the reprocessing methods to ensure the sensor performs "as new." This involves non-clinical tests (biocompatibility, disinfection, shelf life, electrical, tissue heating, pulse rate accuracy, active element assessment, adhesive peel, environmental testing, visual inspection, cleaning efficacy) to establish that the reprocessed device meets specifications. The clinical study mentioned verifies the final performance.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Surgical Instrument and Savings Inc (dba Medline ReNewal) % Stephanie Mays Sr. Regulatory Affairs Specialist, Quality Assurance and Regulatory Affairs Surgical Instrument Service and Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave Redmond, Oregon 97756
Re: K201699
Trade/Device Name: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor (model: MAXNAR) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: June 19, 2020 Received: June 22, 2020
Dear Stephanie Mays:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201699
Device Name
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR
Indications for Use (Describe)
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| OEM DeviceModela | Device Name | OEM |
|---|---|---|
| MAXNAR | Nellcor OxiMax Pulse OximeterSensor(Adult SpO2 Sensor > 40 kg; wovenbandage) | Nellcor PuritanBennett |
| a OEM = original equipment manufacturer. |
K201699 Reprocessed Nellcor OxiMax SpO2 Sensor included in Submission:
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Image /page/4/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue star-like symbol with the word "MEDLINE" in white letters. The logo on the right is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below.
Special 510(k) Notification
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
K201699 Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)1500 NE Hemlock Ave., Redmond, OR 97756 | ||
|---|---|---|---|
| Prepared by/Contact Name | Stephanie Boyle MaysSenior Regulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • E:smays@medline.com | ||
| Date Prepared | June 19, 2020 | ||
| Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2Sensor, model MAXNAR | |
| Common or usual name | Oximeter, reprocessed | ||
| Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 | ||
| Regulatory Class: | Class II | ||
| Product Code: | NLF | ||
| 510(k) number: | K181738 (March 22, 2019) | ||
| Predicate Device | Proprietary/Trade Name: | Medline ReNewal Reprocessed Nellcor OxiMax SpO2Sensors, models MAXA, MAXAL, MAXP, and MAXI | |
| Common or usual name | Oximeter, reprocessed | ||
| Regulatory Name/Reference: | Oximeter; 21 CFR § 870.2700 | ||
| Regulatory Class: | Class II | ||
| Product Code: | NLF | ||
| Panel: | Cardiovascular/anesthesiology | ||
| Manufacturer: | Surgical Instrument Service and Savings(dba Medline ReNewal)1500 NE Hemlock Ave., Redmond, OR 97756 | ||
| Statement of Indications for Use | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor ModelMAXNAR is indicated for single patient use when continuous non-invasivearterial oxygen saturation and pulse rate monitoring is required for adultpatients as indicated in the sensor directions for use. This device is forprescription use only. | ||
| Device Description | The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, modelMAXNAR is designed for the continuous non-invasive monitoring offunctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate inconjunction with a Nellcor Pulse Oximeter. The Medline ReNewalReprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intendedfor prescription use with adult patients in hospitals, hospital-type facilities,and intra-hospital transport. The proposed device is not provided sterile |
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Image /page/5/Picture/1 description: The image shows two logos side by side. The first logo is for Medline, and it features a blue star-like symbol with the word "MEDLINE" in blue letters next to it. The second logo is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller blue letters below it.
Medline ReRenewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
| Statement ofIntended Use | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is indicatedfor the continuous non-invasive monitoring of functional oxygen saturationof arterial hemoglobin (SpO2) and pulse rate. It is intended for use withadult patients in hospitals, hospital-type facilities and intra-hospitaltransport. The device is for prescription use only. |
|---|---|
| Technological(includingfeatures,materials andprinciples ofoperation) | The technological characteristics and the fundamental scientific technologyof the subject device are similar to the predicate devices. The proposeddevice is a reprocessed Nellcor OxiMax SpO2 Sensor as are the deviceswithin the scope of predicate K181738. The proposed device uses use anadhesive bandage, light source (LEDs), photodetector (Faradaycage/photodiode), cable, and connector in the same manner as thepredicate devices. The predicate devices were used to support intendeduse, technological characteristics, and performance specifications. (Alsosee comparison of technological features in the Summary Table) |
| PerformanceTestingNonclinicalTests | The functional characteristics of the predicate and proposed devices wereexamined in K181738 and were evaluated in accordance with PulseOximeters - Premarket Notifications Submissions [510(k)] Guidance forIndustry and Food and Drug Administration Staff (March 4, 2013). Testingincluded:• Biocompatibility: cytotoxicity, sensitization, irritation; acute systemictoxicity• Disinfection• Shelf Life• Electrical• Performance testing:• tissue heating• pulse rate accuracy• active element assessment• adhesive peel and• environment (extreme heat and operating conditions)• Cleaning:• visual inspection;• cleaning efficacy (residual protein and residual hemoglobin). |
| PerformanceTestingClinical Tests | The purpose of the clinical trial in predicate submission K181738 (whichincluded proposed device Model MAXNAR) was to perform an oxygensaturation (SpO2) accuracy comparison. The study was conducted inaccordance with CFR for Non-significant Risk Investigational Studies,following ISO 14155:2011 Clinical Investigation of medical devices forhuman subjects – Good clinical practice as appropriate and the pulseoximeter guidelines of ISO 80601-2-61:2011 Procedure for invasivelaboratory testing on healthy volunteers applicable sections and PulseOximeters - Premarket Notifications Submissions [510(k)] Guidance forIndustry and Food and Drug Administration Staff (March 4, 2013). AfterInstitutional Review Board Approval, 10 healthy adults volunteer subjects(ages 25 to 36 yr.; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 –33.4) were included in the study which was conducted from May 9 to May |
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Image /page/6/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in a stylized font next to a blue star. The second logo is for ReNewal Full Circle Reprocessing, with the word "ReNewal" in green and the words "Full Circle Reprocessing" in blue below it.
| PerformanceTestingClinical Tests(concluded) | SpO2 accuracy of the proposed devices. The proposed devices achievedan accuracy of 2% for 70% - 100% SpO2. The study concluded that theSpO2 accuracy performance of the proposed devices passed the Armsspecification of 3% under steady state and non-motion conditions for therange of 70% to 100%. | ||
|---|---|---|---|
| Device Model | MAXNAR | ||
| Summary Table: Predicate (unmodified) and Proposed (modified) Medline ReNewalReprocessed Nellcor OxiMax SpO2 sensor comparison. | |||
| Predicate | Proposed | ||
| DeviceCharacteristics | Medline ReNewalReprocessedNellcor OxiMaxSpO2 Sensors | Medline ReNewalReprocessedNellcor OxiMaxSpO2 Sensor, MAXNAR | Comparison |
| 510(k) Number | K181738 | TBD | N/A |
| Common Name | Oximeter | Oximeter | Same |
| Regulation No. | 870.2700 | 870.2700 | Same |
| Product Code | NLF | NLF | As stated |
| Models | MAXA, MAXAL, MAXP,and MAXI | MAXNAR | As stated |
| Indications for Use | The Medline ReNewalReprocessed NellcorOxiMax SpO2 Sensorsmodels MAXA, MAXPand MAXI are indicatedfor single patient usewhen continuous non-invasive arterial oxygensaturation and pulse ratemonitoring are requiredfor patients in the sizesindicated in therespective sensordirections for use. Thesedevices are forprescription use only. | The Medline ReNewalReprocessed NellcorOxiMax SpO2 Sensormodel MAXNAR isindicated for singlepatient use whencontinuous non-invasivearterial oxygen saturationand pulse rate monitoringis required for adultpatients as indicated inthe sensor directions foruse. This device is forprescription use only. | Same |
| Intended Use | The reprocessed NellcorOxiMax SpO2 Sensorsare indicated for thecontinuous non-invasivemonitoring of functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulse rate.They are intended for usewith pediatric and adultpatients in hospitals, | The reprocessed NellcorOxiMax SpO2 Sensor isindicated for thecontinuous non-invasivemonitoring of functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulse rate. Itis intended for use withadult patients inhospitals, hospital-type | Same |
| Predicate | Proposed | ||
| DeviceCharacteristics | Medline ReNewalReprocessedNellcor OxiMaxSpO2 Sensors | Medline ReNewalReprocessedNellcor OxiMaxSpO2 Sensor, MAXNAR | Comparison |
| Intended Use(concluded) | hospital-type facilities,and intra-hospitaltransport. These devicesare for prescription useonly. | facilities, and intra-hospital transport.This device is for prescriptionuse only. | Same |
| Comparison oftechnologicalfeatures | The reprocessed NellcorOxiMax SpO2 Sensorsmeasure functionaloxygen saturation non-invasively via a lightsignal interacting withtissue, by utilizing thetime-varying changes intissue optical propertiesthat occur with pulsatileblood flow. Red andinfrared light-emittingdiodes (LEDS) areutilized as light sources.A photodiode acting as aphoto detector sensesthe signal strengths ofthe two wavelengths oflight, which vary with theamount of lighttransmitted through thetissue. The pulseoximeter receives thiselectrical informationfrom the sensor andprocesses theinformation by use of analgorithm to provide realtime values of SpO2,pulse rate and pulseamplitude. | The reprocessed NellcorOxiMax SpO2 Sensormeasures functionaloxygen saturation non-invasively, via a lightsignal interacting withtissue, by utilizing thetime-varying changes intissue optical propertiesthat occur with pulsatileblood flow. Red andinfrared light-emittingdiodes (LEDS) areutilized as light sources.A photodiode acting as aphoto detector sensesthe signal strengths ofthe two wavelengths oflight, which vary with theamount of lighttransmitted through thetissue. The pulseoximeter receives thiselectrical informationfrom the sensor andprocesses theinformation by use of analgorithm to provide realtime values of SpO2,pulse rate and pulseamplitude. | Same |
| Intended patientpopulation | Adult (MAXA, MAXAL),Pediatric (MAXP), Infant(MAXI) | Adult | Same as PredicateMAXA, MAXAL |
| DeviceCharacteristics | PredicateMedline ReNewalReprocessedNellcor OxiMaxSpO2 Sensors | ProposedMedline ReNewalReprocessedNellcor OxiMaxSpO2 Sensor, MAXNAR | Comparison |
| Patient WeightRange | • > 30 kg = adult (MAXA,MAXAL)• 10 - 50 kg = pediatric(MAXP)• 3 - 20 kg = infants (MAXI) | • > 40 kg = adult | SameWithin weightrange of PredicateMAXA, MAXAL |
| Application site | • Finger = MAXA, MAXL,MAXP• Toe or digit of similarsize = MAXI | • Finger | Same as predicateMAXA, MAXAL,MAXP |
| Single Use | Yes | Yes | Same |
| Use Environment | Hospitals, hospital-typefacilities, andintra-hospital transport | Hospitals, hospital-typefacilities, andintra-hospital transport | Same |
| MeasurementParameter | Oxygen saturation, pulserate | Oxygen saturation, pulserate | Same |
| Monitor systemcompatibility | Nellcor OxiMax andNellcor compatible pulseoximeters | Nellcor OxiMax andNellcor compatible pulseoximeters | Same |
| Specified SpO2measurementrange | 70% - 100% (MAXA,MAXAL, MAXP, MAXI) | 70% - 100% | Same |
| SpO2 accuracy | 70% - 100% ± 2 digits inadults (MAXA, MAXAL,MAXP, MAXI) | 70% - 100% ± 2 digits inadults | Same |
| Pulse ratemeasurementrange (bpm) | 20 - 250 bpm (MAXA,MAXAL, MAXP, MAXI) | 20 - 250 bpm | Same |
| Pulse rate accuracy(bpm) | 20 - 250 ± 3 digits(MAXA, MAXAL, MAXP,MAXI) | 20 - 250 ± 3 digits | Same |
| TemperatureOperational/Storage | Operational = 5°C - 40°CStorage = 20°C - 60°C | Operational = 5°C - 40°CStorage = 20°C - 60°C | Same |
| Relative humidity | 15% - 95% non-condensing | 15% - 95% non-condensing | Same |
| DeviceCharacteristics | Predicate | Proposed | |
| Medline ReNewalReprocessedNellcor OxiMaxSpO2 Sensors | Medline ReNewalReprocessedNellcor OxiMaxSpO2 Sensor, MAXNAR | Comparison | |
| Optical design | Transmissive sensor | Transmissive sensor | Same |
| Housing design | Adhesive bandage | Adhesive bandage | Same |
| Conclusion | The subject device has the same intended use as the proposed predicateand the differences in technological features do not raise differentquestions of safety and effectiveness. Based on a comparison of theintended use/indications for use, technological characteristics, andperformance data to the predicate devices, the Medline ReNewalReprocessed Nellcor O2 Sensor, Model MAXNAR is substantiallyequivalent to the predicate device. |
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Image /page/7/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in a stylized font next to a blue star-like symbol. The second logo is for ReNewal, and it features the word "ReNewal" in green and blue, with the words "Full Circle Reprocessing" underneath.
Summary Table (continued)
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Image /page/8/Picture/1 description: The image contains two logos. The first logo is for Medline, and it features the word "MEDLINE" in a stylized font next to a star-like symbol. The second logo is for ReNewal Full Circle Reprocessing, with "ReNewal" in green and blue and "Full Circle Reprocessing" underneath in a smaller font.
Summary Table (continued)
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Image /page/9/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features a blue background with a white star-like symbol and the word "MEDLINE" in white letters. The logo on the right is for ReNewal, and it features the word "ReNewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below.
Summary Table (concluded)
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Image /page/10/Picture/1 description: The image shows two logos side by side. The logo on the left is for Medline, and it features the word "MEDLINE" in blue with a stylized star above it. The logo on the right is for ReNewal Full Circle Reprocessing, with "ReNewal" in green and blue and "Full Circle Reprocessing" in a smaller font below it.
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§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).