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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K092641
Device Name CHARMCARE TABLETOP PULSE OXIMETER
Applicant
CHARMCARE CO., LTD
325 N. PUENTE ST.
UNIT B
BREA,  CA  92821
Applicant Contact JOYCE BANG
Correspondent
CHARMCARE CO., LTD
325 N. PUENTE ST.
UNIT B
BREA,  CA  92821
Correspondent Contact JOYCE BANG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/27/2009
Decision Date 10/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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