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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, Oxygen, Gaseous-Phase
510(k) Number K951038
Device Name OXYCHECK OXYGEN MONITOR
Applicant
OXYCHECK, INC.
454 WASHINGTON ST.
NORWELL,  MA  02061
Applicant Contact GERRY BERKELAAR
Correspondent
OXYCHECK, INC.
454 WASHINGTON ST.
NORWELL,  MA  02061
Correspondent Contact GERRY BERKELAAR
Regulation Number868.1720
Classification Product Code
CCL  
Date Received03/07/1995
Decision Date 01/11/1996
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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