Identifiers
- 510(k) Number
- K855027 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lifestat 1600 is a portable, self-contained pulse oximeter designed to continuously and non-invasively monitor arterial oxygen saturation and pulse rate. It features dual LED numeric displays for oxygen saturation and pulse rate, a bar graph for pulse signal strength, and user-adjustable high and low alarms.
This device includes a built-in battery backup for operation. It is identified by K-number K855027 and has received FDA 510K authorization.
Frequently asked questions
What is the primary function of the Lifestat 1600?
The Lifestat 1600 is designed to continuously and non-invasively monitor a patient's arterial oxygen saturation and pulse rate, providing real-time data through dual LED numeric displays.
Does the device include features for monitoring signal quality and patient safety?
Yes, the device includes a bar graph display to indicate pulse signal strength, as well as user-adjustable high and low alarms to alert clinicians to changes in patient status.
Is the Lifestat 1600 suitable for mobile use?
Yes, the device is designed as a portable, self-contained unit and includes a built-in battery backup to ensure continued operation during transport or in settings where mains power is unavailable.
What is the regulatory status of this pulse oximeter?
The Lifestat 1600, identified by K-number K855027, has received FDA 510K authorization, confirming it has been determined to be substantially equivalent to legally marketed predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Physio-Control Lifestat 1600 Portable Pulse Oximeter SpO2, Biomedical Systems Physio-Control Pulse Oximeter, Physio-Control - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K855027 | Class II | Active |
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Manufacturer
- Manufacturer
- Physio-Control Corp.
Sources (1)
- FDA 510(k) K855027 24 fields · synced Sep 22, 2026