(129 days)
Ohmeda 3760 Pulse Oximeter, Ohmeda Handheld Pulse Oximeter
Ohmeda 3760 Pulse Oximeter, Ohmeda Handheld Pulse Oximeter
No
The description focuses on standard pulse oximetry technology and does not mention AI or ML.
No
The device is described as a monitor that measures arterial oxygen saturation and pulse rate, which are diagnostic indicators. It lacks any mention of treating, preventing, or mitigating a disease or condition.
Yes
The device monitors arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's condition and aid in diagnosis.
No
The device description explicitly mentions hardware components like LED and LCD displays, indicating it is not a software-only device.
Based on the provided text, the Ohmeda Model 3800 Pulse Oximeter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device description: The description clearly states that the device is a "noninvasive, arterial oxygen saturation and pulse rate monitor." This means it measures these parameters directly from the patient's body without requiring a sample to be taken and tested outside the body.
Therefore, the Ohmeda Model 3800 Pulse Oximeter falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
74DQA
Device Description
The Ohmeda Model 3800 Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor. It features two easy-to-read displays that present patient data and status information: a numeric LED (light-emitting diode) display that shows the SpO2 and pulse rate values, and a plethysmographic LCD (liquid crystal display) that shows the waveform, the current high and low SpO2 and pulse rate limit settings, and messages as appropriate. Features
- Several types of Ohmeda sensors for flexibility. ●
- An automatic self-test at start-up. ●
- Automatic tiered alarm messages. .
- Backlit and adjustable viewing-angle display for excellent visibility in subdued lighting conditions. .
- Direct access to user-selectable high and low alarm limits for SpO2 and pulse rate. .
- An audible pulse indicator with an adjustable volume; the automatic pitch modulation reflects ● changing SpO2 level.
- Visual and audible (adjustable volume) alarms.
- An alarm-silence feature; silences audible alams continuously until deactivated. ●
- Status and alarm informational messages appear on the LCD. .
- Short, medium, or long SpO2 response averaging modes. 0
- . Adult or neonatal patient modes for default pulse rate alarm settings.
- Fractional or functional SpO2 calibration modes. ●
- Automatic storage of up to 12 hours of SpO2, pulse-rate, and alarm limit violations data in trend . memory, which can be output through the RS-232 serial connector.
- Rechargeable, sealed, lead-acid battery backup operation, including low battery status reporting. .
- Automatic scale plethysmographic waveform to provide a relative indication of the sensor site . perfusion level.
- Larger SpO2 digital display for clear differentiation from the pulse rate value. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult or neonatal patient modes for default pulse rate alarm settings.
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Ohmeda 3760 Pulse Oximeter, Ohmeda Handheld Pulse Oximeter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows a date, "OCT 10 1996". The month is October, the day is the 10th, and the year is 1996. The text is in a bold, sans-serif font.
Image /page/0/Picture/1 description: The image shows the word "OHMEDA" in a bold, sans-serif font. A symbol resembling a snake is placed vertically below the "H" and "M" of the word. The letters are large and black, contrasting with the white background.
W THE BOC GROUP
Mav 30, 1996
Ohmeda Inc Ohmeda Drive PO Box 7550 Madison WI 53707-7550 608 221 1551
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Ohmeda 3800 Pulse Oximeter. |
|---|---|
| Proprietary: | Ohmeda 3800 Pulse Oximeter |
| Common: | Oximeter |
| Classification: | Oximeter Class II - 21CFR870.2700 - 74DQA |
b
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The Ohmeda 3800 Pulse Oximeter is substantially equivalent to the currently marketed Ohmeda 3760 Pulse Oximeter and the Ohmeda Handheld Pulse Oximeter.
The Ohmeda Model 3800 Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor. It features two easy-to-read displays that present patient data and status information: a numeric LED (light-emitting diode) display that shows the SpO2 and pulse rate values, and a plethysmographic LCD (liquid crystal display) that shows the waveform, the current high and low SpO2 and pulse rate limit settings, and messages as appropriate. Features
- Several types of Ohmeda sensors for flexibility. ●
- An automatic self-test at start-up. ●
- Automatic tiered alarm messages. .
- Backlit and adjustable viewing-angle display for excellent visibility in subdued lighting conditions. .
- Direct access to user-selectable high and low alarm limits for SpO2 and pulse rate. .
- An audible pulse indicator with an adjustable volume; the automatic pitch modulation reflects ● changing SpO2 level.
- Visual and audible (adjustable volume) alarms.
- An alarm-silence feature; silences audible alams continuously until deactivated. ●
- Status and alarm informational messages appear on the LCD. .
- Short, medium, or long SpO2 response averaging modes. 0
- . Adult or neonatal patient modes for default pulse rate alarm settings.
- Fractional or functional SpO2 calibration modes. ●
- Automatic storage of up to 12 hours of SpO2, pulse-rate, and alarm limit violations data in trend . memory, which can be output through the RS-232 serial connector.
- Rechargeable, sealed, lead-acid battery backup operation, including low battery status reporting. .
- Automatic scale plethysmographic waveform to provide a relative indication of the sensor site . perfusion level.
- Larger SpO2 digital display for clear differentiation from the pulse rate value. .
The software for the Ohmeda 3800 Pulse Oximeter has been developed following a rigorous software development process and has been fully specified and validated by Ohmeda.
The Ohmeda 3800 Pulse Oximeter complies with the following standards:
-
- CSA C22.2 #601
-
- IEC 601-1, Part 1 and Amendment 1
- IEC 601-1-1, Part 1 3.
- IEC 601-1-2, Part 1 ﻬ
- IEC 601-1-4, Part 1 ട്.
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- ISO 9919 (1992)
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- UL 2601-1
The Ohmeda 3760 Pulse Oximeter, the Ohmeda Handheld Pulse Oximeter and the Ohmeda 3800 Pulse Oximeter are substantially equivalent in technological characteristics, theory of operation and measurement methods. The Ohmeda 3800 Pulse Oximeter is the next generation of oximeter, utilizing the technological advances of today to bring Ohmeda oximeters to the next century.
Image /page/0/Picture/36 description: The image shows a sequence of digits, specifically "00035". The digits are bold and slightly distorted, giving them a somewhat rough or aged appearance. The numbers are evenly spaced and horizontally aligned.