PROBE REFILL KIT

Transducer, Ultrasonic, Diagnostic

INTERSPEC, INC.

The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Probe Refill Kit.

Pre-market Notification Details

Device IDK911073
510k NumberK911073
Device Name:PROBE REFILL KIT
ClassificationTransducer, Ultrasonic, Diagnostic
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 CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-11
Decision Date1991-06-06

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