CARDIOSCAN WITH DOPPLER OPTION

Transducer, Ultrasonic

INTERSPEC, INC.

The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Cardioscan With Doppler Option.

Pre-market Notification Details

Device IDK862913
510k NumberK862913
Device Name:CARDIOSCAN WITH DOPPLER OPTION
ClassificationTransducer, Ultrasonic
Applicant INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken,  PA  19428
ContactSchafer, M.sc.
CorrespondentSchafer, M.sc.
INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken,  PA  19428
Product CodeJOP  
CFR Regulation Number870.2880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-01
Decision Date1986-11-04

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