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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
510(k) Number K851451
Device Name STAT GAS MODULE
Applicant
VULCAN LABORATORIES, INC.
8038 RUGBY AVE.
BIRMINGHAM,  AL  35206
Applicant Contact JOE EMRICO
Correspondent
VULCAN LABORATORIES, INC.
8038 RUGBY AVE.
BIRMINGHAM,  AL  35206
Correspondent Contact JOE EMRICO
Regulation Number868.2500
Classification Product Code
KLK  
Date Received04/11/1985
Decision Date 08/02/1985
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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