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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 K952941
Device Name SUN MODEL OA 3000 OXYGEN ANALYZER
Applicant
SUN MEDICAL EQUIPMENT, INC.
1825 S. DIVISION AVE.
ORLANDO,  FL  32806
Applicant Contact DANNY SHEETZ
Correspondent
SUN MEDICAL EQUIPMENT, INC.
1825 S. DIVISION AVE.
ORLANDO,  FL  32806
Correspondent Contact DANNY SHEETZ
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/26/1995
Decision Date 01/29/1996
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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