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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K974372
Device Name AIR OXYGE MIXER
Applicant
SK MED
16000 SHERMAN WAY #224
VAN NUYS,  CA  91406
Applicant Contact DIPAK GHOSH
Correspondent
SK MED
16000 SHERMAN WAY #224
VAN NUYS,  CA  91406
Correspondent Contact DIPAK GHOSH
Regulation Number868.5330
Classification Product Code
BZR  
Date Received11/20/1997
Decision Date 02/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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