(458 days)
Not Found
No
The description focuses on standard oscillometry techniques and hardware components (cuff, analog circuit, MCU) without mentioning any AI/ML algorithms or capabilities. The performance studies listed are standard tests for blood pressure monitors.
No.
The device is a diagnostic tool for measuring blood pressure and pulse rate, not for directly treating a medical condition.
Yes
Explanation: The device is intended to measure blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in the diagnosis of conditions such as hypertension.
No
The device description explicitly states it consists of "external hardwares (such as cuff), analog circuit, and MCU," indicating it includes physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device function: The Med-link Blood Pressure Monitor measures blood pressure and pulse rate directly on the patient's body using a cuff. It does not analyze any specimens taken from the body.
The device described is a non-invasive medical device used for physiological measurement.
N/A
Intended Use / Indications for Use
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
Product codes
DXN
Device Description
The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models:
Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist, Upper Arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
medical professionals or at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of safety, essential performance and biocompatibility tests were performed to assess the safety and effectiveness of Med-link Digital Blood Pressure Monitor. The tests listed below were conducted in accordance with
IEC 60601-1 Medical electrical equipment-Part 1:General requirements for basic safety, and essential performance.
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 80601-2-30, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Biological Evaluation of medical devices-Part 5: Test for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests For Irritation And Skin Sensitization
- . Cytotoxicity Test
- Skin irritation Test ●
- Skin Sensitization Test .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pressure: ±3mmHg
Pulse: ±5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 2, 2019
Shenzhen Med-link Electronics Tech Co, Ltd. Baihan Feng Regulatory Affairs Specialist 4th Fl, Bldg A, Yingtailong Industrial Prk, Dalang South Road, Longhua District Shenzhen. 518109 CHINA
Re: K181154
Trade/Device Name: Med-link Wrist Digital Blood Pressure Monitor Model: ESM101, Med-link Upper Arm Digital Blood Pressure Monitor Model: ESM201 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 28, 2019 Received: July 1, 2019
Dear Baihan Feng:
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.
1
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 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,
Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181154
Device Name
Med-link Wrist Digital Blood Pressure Monitor Model:ESM101 Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
Indications for Use (Describe)
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
| 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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Image /page/3/Picture/1 description: The image shows the logo for MEDLINKET. The logo consists of the word "MED" in red, with a blue arc extending from the bottom of the "M" to the top of the "D". A red circle is placed to the right of "MED", and the word "LINKET" is written in blue to the right of the circle. The letters "TM" are written in a smaller font size above the "T" in "LINKET".
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. Type of submission: Traditional
The assigned 510(k) number is:
1. Submitter information
Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th Fl, Bldg A, Yingtailong Industrial Park, Dalang South Road, Longhua District, Shenzhen, Guangdong, CHINA, 518109 Tel: 0086-755-61568825 Fax: 0086-755-61120055 Establishment Registration Number: 3006636961
2. Contact Person
Baihan Feng (Primary Contact) E-mail: MDL001@medlinket.com
Fei Liu E-mail: USER22@med-linket.com
-
- Data of Submission
28th , Jun., 2019
- Data of Submission
4. Identification of the Device
Trade Name: Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
Common Name: Non-invasive blood pressure measurement system
Classification Regulation: 21 CFR 870.1130
Product Code: DXN
Identification of the Predicate Device 5.
Table 1 Predicate Device Information
| No. | Device Name | Common | Manufacture | Classifica | Classifi | 510(k) |
|---|---|---|---|---|---|---|
| ----- | ------------- | -------- | ------------- | ------------ | ---------- | -------- |
4
Image /page/4/Picture/1 description: The image shows the logo for MEDLINKET. The logo has the word "MED" in red, with a blue arc underneath it. To the right of the arc is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in superscript to the right of the word "LINKET".
| | | Name | | tion and
Code | cation
regulati
on | number | |
|--|---|------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------|--------------------------|------------------------|---------|
| | 1 | Full
Automatic(NIBP)
Blood Pressure
Monitor, Model
HL158LA | Blood
Pressure
Monitor | Health & Life
Co.,Ltd. | Class II,
DXN | 21 CFR
870.113
0 | K130564 |
| | 2 | AGE Automatic
Upper Arm Blood
Pressure Monitor | Noninvasi
ve blood
pressure
measurem
ent system | Ageless Health
Industrial Ltd. | Class II,
DXN | 21 CFR
870.113
0 | K123882 |
6. Indications for Use of the Subject device
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
7. Device Description
The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models:
Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
5
Image /page/5/Picture/1 description: The image shows the logo for MED LINKET. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of the word "MED" is a red circle, followed by the word "LINKET" in blue.
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
8. Test Summary
A series of safety, essential performance and biocompatibility tests were performed to assess the safety and effectiveness of Med-link Digital Blood Pressure Monitor. The tests listed below were conducted in accordance with
IEC 60601-1 Medical electrical equipment-Part 1:General requirements for basic safety, and essential performance.
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 80601-2-30, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Biological Evaluation of medical devices-Part 5: Test for in vitro cytotoxicity
ISO 10993-10 Biological evaluation of medical devices- Part 10: Tests For Irritation And Skin Sensitization
- . Cytotoxicity Test
- Skin irritation Test ●
- Skin Sensitization Test .
9. Substantial Equivalence Determination
| Item | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade name | Med-link Wrist Digital Blood | |
| Pressure Monitor | Full Automatic(NIBP) Blood | |
| Pressure Monitor, Model | ||
| HL158LA | ||
| 510(K) Submitter | Shenzhen Med-link Electronics | |
| Tech Co., Ltd. | Health & Life Co.,Ltd. | |
| 510(K) Number | — | K130564 |
| Classification | ||
| Regulation | 21CRF 870.1130 | 21CRF 870.1130 |
| Item | Proposed Device | Primary Predicate Device |
| Classification | ||
| and Code | Class II, | |
| DXN | Class II, | |
| DXN | ||
| Common name | Noninvasive blood pressure | |
| measurement system | Blood | |
| Pressure | ||
| Monitor | ||
| Type of Use | OTC | OTC |
| Indications for | ||
| Use | Med-link Wrist Digital Blood | |
| Pressure Monitor is non-invasive | ||
| blood measurement of arterial | ||
| blood pressure values in adults. It | ||
| is intended to measure the | ||
| diastolic, systolic blood pressures | ||
| and pulse rate through an | ||
| inflatable cuff wrapped around the | ||
| wrist. It can be used by medical | ||
| professionals or at home. The cuff | ||
| circumference is limited to | ||
| 13.5-19.5 cm. | HL158LA automatically | |
| measures human' s Systolic, | ||
| Diastolic blood pressure and | ||
| heart rate by using the | ||
| oscillometric method. All | ||
| values can be read out in one | ||
| LCD panel. Measurement | ||
| position is at human being' s | ||
| wrist. The intended use of | ||
| this over-the-counter device | ||
| is for use by people over the | ||
| age of 18 with wrist | ||
| circumference ranging from | ||
| approx. 5.3 to 7.7 | ||
| inches(13.5 cm to 19.5 cm) | ||
| and for home use. | ||
| Patient | ||
| populations | Adult | Adult |
| Method of | ||
| Measurement | Oscillometric | Oscillometric |
| Measurement | ||
| Site | Wrist | Wrist |
| Measurement | ||
| Range | Pressure: 0~280 mmHg | |
| Pulse: 40~199 beats/minute | Pressure: 0~280 mmHg | |
| Pulse: 40~199 beats/minute | ||
| Accuracy | Pressure: ±3mmHg | |
| Pulse: ±5% | Pressure: ±3mmHg | |
| Pulse: ±5% | ||
| Item | Proposed Device | Primary Predicate Device |
| Inflation and | ||
| Deflation | Automatic | Automatic |
| Display | LCD | LCD |
| Memory | 2x90 sets | 4x30 sets |
| Cuff Size | 13.5cm~19.5cm | 13.5cm~19.5cm |
| Voice broadcast | Yes | Not-provided |
| Power Supply | DC 3.0V (2xAAA alkaline | |
| battery) | DC 3.0V (2xAAA alkaline | |
| battery) | ||
| Operation | ||
| Environment | Temperature: +5° C~+40° C; | |
| Humidity: 15%~85%RH, | Temperature: +5° C~+40° | |
| C; | ||
| Humidity: 15%~93%RH | ||
| Storage | ||
| Environment | Temperature: -20° C~+55° C | |
| Humidity: ≤95%RH, | ||
| non-condensing | Temperature: -25° C~+70° | |
| C | ||
| Humidity: ≤95%RH, | ||
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1, |
| IEC 60601-1-11 | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Performance | ISO 80601-2-30 and ISO 81060-2 | AAMI SP10 |
| Biocompatibility | ||
| Evaluation | All the patient contracting | |
| materials are evaluated by the | ||
| biocompatibility standard ISO | ||
| 10993-1, -5, -10. | All the patient contracting | |
| materials are evaluated by | ||
| the | ||
| biocompatibility standard | ||
| ISO 10993-1, -5, -10. |
Table 2 Comparison Table for Med-link Wrist Digital Blood Pressure Monitor ESM101
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Image /page/6/Picture/1 description: The image shows the logo for MEDLINKET. The logo features the word "MED" in red, with a blue arc underneath it. To the right of "MED" is a red circle, followed by the word "LINKET" in blue, with the trademark symbol above it.
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Image /page/7/Picture/1 description: The image shows the logo for MEDLINKET. The logo consists of the word "MED" in red, with a blue arc underneath it. To the right of the arc is a red circle, followed by the word "LINKET" in blue. The letters "TM" are in superscript to the right of the word "LINKET".
Table 3 Comparison Table for Med-link Upper Arm Digital Blood Pressure Monitor ESM201
| Item | Proposed Device | Primary Predicate Device |
|---|---|---|
| Trade name | Med-link Upper Arm Digital | |
| Blood Pressure Monitor | AGE Automatic Upper Arm | |
| Blood Pressure Monitor | ||
| 510(K) Submitter | Shenzhen Med-link Electronics | |
| Tech Co., Ltd. | Ageless Health Industrial | |
| Ltd. | ||
| 510(K) Number | — | K123882 |
| Classification | ||
| Regulation | 21CRF 870.1130 | 21CRF 870.1130 |
| Item | Proposed Device | Primary Predicate Device |
| Classification | ||
| and Code | Class II, | |
| DXN | Class II, | |
| DXN | ||
| Common name | Noninvasive blood pressure | |
| measurement system | Noninvasive blood pressure | |
| measurement system | ||
| Type of Use | OTC | OTC |
| Indications for | ||
| Use | Med-link Upper Arm Digital | |
| Blood Pressure Monitor is | ||
| non-invasive measurement of | ||
| arterial blood pressure values in | ||
| adults. It is intended to measure | ||
| the diastolic, systolic blood | ||
| pressures and pulse rate through | ||
| an inflatable cuff wrapped around | ||
| the upper arm. It can be used by | ||
| medical professionals or at home. | ||
| The cuff circumference is limited | ||
| to 22-32cm. | AGE Automatic Upper Arm | |
| Blood Pressure Monitor is | ||
| for use by medical | ||
| professionals or at home and | ||
| is a non-invasive blood | ||
| pressure measurement | ||
| system intended to measure | ||
| the diastolic and systolic | ||
| blood pressures and pulse | ||
| rate of an adult individual by | ||
| using a non-invasive | ||
| technique in which an | ||
| inflatable cuff is wrapped | ||
| around the upper arm. The | ||
| cuff circumference is limited | ||
| to 24-34cm. | ||
| Patient | ||
| populations | Adult | Adult |
| Method of | ||
| Measurement | Oscillometric | Oscillometric |
| Measurement | ||
| Site | Upper Arm | Upper Arm |
| Measurement | ||
| Range | Pressure: 0~280 mmHg | |
| Pulse: 40~199 beats/minute | Pressure: 0~280 mmHg | |
| Pulse: 40~199 beats/minute | ||
| Accuracy | Pressure: ±3mmHg | |
| Pulse: ±5% | Pressure: ±3mmHg | |
| Pulse: ±5% | ||
| Inflation and | ||
| Deflation | Automatic | Automatic |
| Item | Proposed Device | Primary Predicate Device |
| Display | LCD | LCD |
| Memory | 2x90 sets | 2x90 sets |
| Cuff Size | 22cm~32cm | 24cm~34cm |
| Voice broadcast | Yes | Yes |
| Power Supply | DC 6.0V (4xAA alkaline battery) | DC 6.0V (4xAA alkaline battery) |
| Operation | ||
| Environment | Temperature: +5°C~+40°C; | |
| Humidity: 15%~85%RH, | Temperature: +5°C~+40°C; | |
| Humidity: 10%~95%RH | ||
| Storage | ||
| Environment | Temperature: -20°C~+55°C | |
| Humidity: ≤95%RH | Temperature: -20°C~+65°C | |
| Humidity: 10%~95%RH | ||
| Electrical Safety | Comply | |
| with IEC 60601-1 | Comply with IEC 60601-1 | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Performance | ISO 80601-2-30 and ISO 81060-2 | AAMI SP10 |
| Biocompatibility | ||
| Evaluation | All the patient contracting | |
| materials are evaluated by the | ||
| biocompatibility standard ISO | ||
| 10993-1, -5, -10. | All the patient contracting | |
| materials are evaluated by the | ||
| biocompatibility standard ISO | ||
| 10993-1, -5, -10. |
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Image /page/8/Picture/1 description: The image shows the logo for MED LINKET. The logo has the word "MED" in red, with a blue swoosh underneath it. To the right of "MED" is a red circle, and then the word "LINKET" in blue. There is a small "TM" in the upper right corner of the word "LINKET".
9
Image /page/9/Picture/1 description: The image shows the logo for MED Linket. The logo has the letters "MED" in red, with a blue swoosh underneath. To the right of the letters is a red circle, and then the word "LINKET" in blue. There is a small "TM" symbol in the upper right corner of the word "LINKET".
The proposed device and its predicate devices have the identical indented use, principle and performance. The differences between the proposed device and the predicate device do not raise any question regarding its safety and effectiveness.
10. Conclusion
Based on the comparison and analysis in this submission, it can be concluded that: Med-link Upper Digital Blood Pressure Monitors are substantially equivalent to the predicate devices in regard to safety and effectiveness.