INTERSPEC APOGEE CLA

System, Imaging, Pulsed Echo, Ultrasonic

INTERSPEC, INC.

The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec Apogee Cla.

Pre-market Notification Details

Device IDK924231
510k NumberK924231
Device Name:INTERSPEC APOGEE CLA
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler,  PA  19002
ContactArthur J Schenck
CorrespondentArthur J Schenck
INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler,  PA  19002
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-21
Decision Date1993-06-14

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