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Life Watch Respiratory Monitor

by The Perkin-Elmer Corp.

510(k) K853840

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853840 Date9 Dec 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CHL
Device Class
Class II
Regulation
21 CFR Part 862.1120
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Life Watch Respiratory Monitor is a device designed to measure or monitor a patient's respiratory rate. It functions as a breathing frequency monitor that can provide an audible or visible alarm when the respiratory rate, averaged over time, falls outside of operator-settable alarm limits.

This device is regulated under FDA 510(k) clearance number K853840. It is classified under regulation number 862.1120 within the clinical chemistry medical specialty.

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