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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Transducer, Gas Flow
510(k) Number K920360
Device Name TIMOX OXYGEN TIMER
Applicant
Medical Fittings, Inc.
300 Held Dr.
Northampton,  PA  18067
Applicant Contact JOHN R SELADY
Correspondent
Medical Fittings, Inc.
300 Held Dr.
Northampton,  PA  18067
Correspondent Contact JOHN R SELADY
Regulation Number868.2885
Classification Product Code
BXP  
Date Received01/27/1992
Decision Date 08/03/1992
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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