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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K870661
Device Name LIFEWATCH PLUS
Applicant
The Perkin-Elmer Corp.
2771 N. Garey Ave.
P.O. Box 2801
Pomona,  CA  91767
Applicant Contact MCCLEARY, JR.
Correspondent
The Perkin-Elmer Corp.
2771 N. Garey Ave.
P.O. Box 2801
Pomona,  CA  91767
Correspondent Contact MCCLEARY, JR.
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received02/19/1987
Decision Date 03/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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