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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 K973991
Device Name METRON QA-510 SPO2 ANALYZER
Applicant
Metron U.S., Inc.
P.O. Box 4343
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Metron U.S., Inc.
P.O. Box 4343
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/21/1997
Decision Date 01/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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