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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K853840
Device Name LIFE WATCH RESPIRATORY MONITOR
Applicant
THE PERKIN-ELMER CORP.
2771 NORTH GAREY AVE.
P.O. BOX 2801
POMONA,  CA  91767
Applicant Contact HAERR
Correspondent
THE PERKIN-ELMER CORP.
2771 NORTH GAREY AVE.
P.O. BOX 2801
POMONA,  CA  91767
Correspondent Contact HAERR
Regulation Number862.1120
Classification Product Code
CHL  
Date Received09/16/1985
Decision Date 12/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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