Cleared Traditional

K853840 - LIFE WATCH RESPIRATORY MONITOR
(FDA 510(k) Clearance)

K853840 · The Perkin-Elmer Corp. · Chemistry

Dec 1985

Decision

84d

Days

Class 2

Risk

K853840 is an FDA 510(k) clearance for the LIFE WATCH RESPIRATORY MONITOR, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by The Perkin-Elmer Corp. (Pomona, US). The FDA issued a Cleared decision on December 9, 1985, 84 days after receiving the submission on September 16, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number	K853840 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1985
Decision Date	December 09, 1985
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—