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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K936156
Device Name VENTILATION MECHANICS MONITOR MODEL VMM-100
Applicant
SMITH INDUSTRIES MEDICAL SYSTEMS (SIMS)
2552 MCGAW AVE.
IRVINE,  CA  92714
Applicant Contact GORDON SHIGEZAWA
Correspondent
SMITH INDUSTRIES MEDICAL SYSTEMS (SIMS)
2552 MCGAW AVE.
IRVINE,  CA  92714
Correspondent Contact GORDON SHIGEZAWA
Regulation Number868.5895
Classification Product Code
MOD  
Date Received12/27/1993
Decision Date 06/27/1995
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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