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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 K801104
Device Name ROOMMATE-OXYGEN CONCENTRATOR
Applicant
Cryogenic Assoc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cryogenic Assoc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/09/1980
Decision Date 05/23/1980
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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