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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 K083079
Device Name QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100
Applicant
QUANTA COMPUTER INC.
2904 N. BOLDT DR.
FLAGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
QUANTA COMPUTER INC.
2904 N. BOLDT DR.
FLAGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/16/2008
Decision Date 03/05/2009
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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