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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K823861
Device Name ET-3 EMERGENCY TRANSPORT VENTILATOR
Applicant
BIO-MED DEVICES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIO-MED DEVICES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/22/1982
Decision Date 02/07/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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