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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 K834274
Device Name CRITERION I
Applicant
TIMETER INSTRUMENT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TIMETER INSTRUMENT CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/08/1983
Decision Date 04/13/1984
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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