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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, monitoring (w/wo alarm)
510(k) Number K823780
Device Name RESPITRACE 300SC
Applicant
RESPITRACE CORP.
731 SAW MILL RD.
ARDSLEY,  NY  10502
Applicant Contact WILLIAM GRUEN
Correspondent
RESPITRACE CORP.
731 SAW MILL RD.
ARDSLEY,  NY  10502
Correspondent Contact WILLIAM GRUEN
Regulation Number868.1850
Classification Product Code
BZK  
Date Received12/15/1982
Decision Date 01/20/1984
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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