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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
Minesafety Appliances Co.
P.O. Box 427
Pittsburgh,  PA  15230
Applicant Contact THOMAS P MCCLORY
Correspondent
Minesafety 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
Predetermined Change
Control Plan Authorized		 No
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