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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 K031860
Device Name SK MED ME202 MONITORING 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  
Subsequent Product Code
CCL  
Date Received06/16/2003
Decision Date 01/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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