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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K881303
Device Name TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER
Applicant
Triton Technology, Inc.
P.O. Box 99185
San Diego,  CA  92109
Applicant Contact SCOTT KEMPER
Correspondent
Triton Technology, Inc.
P.O. Box 99185
San Diego,  CA  92109
Correspondent Contact SCOTT KEMPER
Regulation Number870.2120
Classification Product Code
DPT  
Date Received03/28/1988
Decision Date 11/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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