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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 K822635
Device Name 225 S.I.M.V. VENTILATOR
Applicant
MONAGHAN MEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MONAGHAN MEDICAL CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/31/1982
Decision Date 11/16/1982
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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