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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 K872441
Device Name HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR
Applicant
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Applicant Contact JOHN DELLINGER
Correspondent
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Correspondent Contact JOHN DELLINGER
Regulation Number870.2120
Classification Product Code
DPT  
Date Received06/19/1987
Decision Date 02/19/1988
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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