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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 K780458
Device Name TRANSCUTANEOUS OXYGEN PERFUSION MONITOR
Applicant
NARCO AIR-SHIELDS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NARCO AIR-SHIELDS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2500
Classification Product Code
KLK  
Date Received03/23/1978
Decision Date 10/10/1978
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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