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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 K871603
Device Name CRITERION II & IIA OXYGEN CONCENTRATORS
Applicant
TIMETER INSTRUMENT CORP.
2501 OREGON PIKE
LANCASTER,  PA  17601
Applicant Contact ROBERT A FRITZ
Correspondent
TIMETER INSTRUMENT CORP.
2501 OREGON PIKE
LANCASTER,  PA  17601
Correspondent Contact ROBERT A FRITZ
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/24/1987
Decision Date 08/13/1987
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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