510(k) K853840

LIFE WATCH RESPIRATORY MONITOR by The Perkin-Elmer Corp. — Product Code CHL

K853840 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "LIFE WATCH RESPIRATORY MONITOR". The FDA issued a decision of Substantially Equivalent on December 9, 1985. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1985
Date Received
September 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type