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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 K883158
Device Name RESPIRATORY AIRWAY TUBE MONITOR (RATM)
Applicant
VASCUCARE, INC.
40 RAMLAND RD. SOUTH
ORANGEBURG,  NY  10962
Applicant Contact SUZANNE LETSO
Correspondent
VASCUCARE, INC.
40 RAMLAND RD. SOUTH
ORANGEBURG,  NY  10962
Correspondent Contact SUZANNE LETSO
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/26/1988
Decision Date 03/06/1989
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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