DOPPLEX SURGICAL PROBES

Transducer, Ultrasonic, Diagnostic

HNE HEALTHCARE, INC.

The following data is part of a premarket notification filed by Hne Healthcare, Inc. with the FDA for Dopplex Surgical Probes.

Pre-market Notification Details

Device IDK946300
510k NumberK946300
Device Name:DOPPLEX SURGICAL PROBES
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant HNE HEALTHCARE, INC. 227 ROUTE 33 EAST Manalapan,  NJ  07726
ContactAudrey Witko
CorrespondentAudrey Witko
HNE HEALTHCARE, INC. 227 ROUTE 33 EAST Manalapan,  NJ  07726
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-28
Decision Date1995-07-26

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