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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name generator, oxygen, portable
510(k) Number K935370
Device Name MINIOX IA OXYGEN ANALYZER
Applicant
MINE SAFETY APPLIANCES, CO.
P.O. BOX 427
PITTSBURGH,  PA  15230
Applicant Contact THOMAS P MCCLORY
Correspondent
MINE SAFETY APPLIANCES, CO.
P.O. BOX 427
PITTSBURGH,  PA  15230
Correspondent Contact THOMAS P MCCLORY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/04/1993
Decision Date 08/02/1994
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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