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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 K882377
Device Name HEALTH-WATCH BED MONITOR
Applicant
ENGINEERING DEVELOPMENTS, CO.
47 WILLOW RD.
TINTON FALLS,  NJ  07724
Applicant Contact CARL ORLANDO
Correspondent
ENGINEERING DEVELOPMENTS, CO.
47 WILLOW RD.
TINTON FALLS,  NJ  07724
Correspondent Contact CARL ORLANDO
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received06/08/1988
Decision Date 11/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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