← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K962127 # OHMEDA 3800 PULSE OXIMETER (K962127) _Ohmeda Medical · DQA · Oct 10, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K962127 ## Device Facts - **Applicant:** Ohmeda Medical - **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md) - **Decision Date:** Oct 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2700 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Pediatric ## Indications for Use The Ohmeda Model 3800 Pulse Oximeter is a noninvasive, arterial oxygen saturation and pulse rate monitor. ## Device Story Noninvasive monitor; measures arterial oxygen saturation (SpO2) and pulse rate via compatible Ohmeda sensors. Inputs: optical signals from sensors; processes via internal circuitry to calculate SpO2 and pulse rate. Outputs: numeric LED display for SpO2/pulse rate; LCD for plethysmographic waveform, alarm limits, and status messages. Used in clinical settings by healthcare providers. Features: automatic self-test, tiered alarms, adjustable pulse pitch modulation, trend memory (12 hours), RS-232 output, and battery backup. Provides real-time physiological data to assist clinicians in patient status assessment and alarm management. ## Clinical Evidence Bench testing only. Device complies with safety and performance standards including CSA C22.2 #601, IEC 601-1 (Parts 1, 1-1, 1-2, 1-4), ISO 9919 (1992), and UL 2601-1. ## Technological Characteristics Noninvasive pulse oximetry; LED/LCD display; RS-232 connectivity; rechargeable sealed lead-acid battery. Complies with IEC 601-1, ISO 9919, and UL 2601-1 standards. Features automatic self-test, tiered alarm system, and plethysmographic waveform scaling. ## Regulatory 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. ## Predicate Devices - Ohmeda 3760 Pulse Oximeter - Ohmeda Handheld Pulse Oximeter ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} OCHMEDA OCT 10 1996 K962127 The BOC Group Ohmeda Inc Ohmeda Drive PO Box 7550 Madison WI 53707-7550 608 221 1551 May 30, 1996 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 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 alarms continuously until deactivated. - Status and alarm informational messages appear on the LCD. - Short, medium, or long SpO₂ response averaging modes. - 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: 1. CSA C22.2 #601 2. IEC 601-1, Part 1 and Amendment 1 3. IEC 601-1-1, Part 1 4. IEC 601-1-2, Part 1 5. IEC 601-1-4, Part 1 6. ISO 9919 (1992) 7. 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. 000035 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K962127](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K962127) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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