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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K925459
Device Name GS-MODULAR (GOLD STANDARD - MODULAR)
Applicant
WARREN E. COLLINS, INC.
220 WOOD RD.
BRAINTREE,  MA  02184 -2408
Applicant Contact JAMES J TULLY
Correspondent
WARREN E. COLLINS, INC.
220 WOOD RD.
BRAINTREE,  MA  02184 -2408
Correspondent Contact JAMES J TULLY
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/29/1992
Decision Date 02/04/1994
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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