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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K041781
Device Name VENTILAIR II MEDICAL AIR COMPRESSOR
Applicant
HAMILTON MEDICAL AG
PO BOX 30008
RENO,  NV  89502
Applicant Contact J. DAVID THOMPSON
Correspondent
HAMILTON MEDICAL AG
PO BOX 30008
RENO,  NV  89502
Correspondent Contact J. DAVID THOMPSON
Regulation Number868.6250
Classification Product Code
BTI  
Date Received07/01/2004
Decision Date 03/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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