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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
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