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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K960831
Device Name VENTRAK RMMS 1550
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD,  CT  06492
Applicant Contact ROBERT H SCHIFFMAN, R.A.C.
Correspondent
NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD,  CT  06492
Correspondent Contact ROBERT H SCHIFFMAN, R.A.C.
Regulation Number868.1880
Classification Product Code
BZC  
Date Received02/29/1996
Decision Date 05/29/1996
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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