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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 K874442
Device Name DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
Applicant
CRITIKON COMPANY,LLC
4110 GEORGE RD.
P.O. BOX 22800
TAMPA,  FL  33630
Applicant Contact RAYMOND E URSICK
Correspondent
CRITIKON COMPANY,LLC
4110 GEORGE RD.
P.O. BOX 22800
TAMPA,  FL  33630
Correspondent Contact RAYMOND E URSICK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/28/1987
Decision Date 02/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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