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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-monoxide, gaseous-phase
510(k) Number K952694
Device Name CO BREATH ANALYSIS MODULE & MONOXOL II
Applicant
BACHARACH, INC.
7475 WISCONSIN AVE.
SUITE 850
BETHESDA,  MD  20814
Applicant Contact EDWARD MARCH
Correspondent
BACHARACH, INC.
7475 WISCONSIN AVE.
SUITE 850
BETHESDA,  MD  20814
Correspondent Contact EDWARD MARCH
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received06/14/1995
Decision Date 01/29/1996
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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