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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K812873
Device Name MEDICON #8200 AMS
Applicant
MEDICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received10/14/1981
Decision Date 11/16/1981
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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