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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 K830488
Device Name VENTILATOR #1
Applicant
Ohio Medical Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ohio Medical Products
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/15/1983
Decision Date 09/15/1983
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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