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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 K072235
Device Name PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
Applicant
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
55 NORTHERN BLVD., SUITE 200
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/10/2007
Decision Date 10/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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