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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K813453
Device Name UNIT, LIQUID, OXYGEN, PORTABLE
Applicant
Pensee Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pensee Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received12/10/1981
Decision Date 01/12/1982
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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