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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 K811628
Device Name OECO APNEA MONITOR
Applicant
OECO
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
OECO
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received06/09/1981
Decision Date 07/31/1981
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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