RHEO DOPPLEX II (RD 2)

System, Imaging, Pulsed Doppler, Ultrasonic

HUNTLEIGH TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Rheo Dopplex Ii (rd 2).

Pre-market Notification Details

Device IDK964699
510k NumberK964699
Device Name:RHEO DOPPLEX II (RD 2)
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant HUNTLEIGH TECHNOLOGY, INC. 227 RTE. 33 EAST Manalapan,  NJ  07726
ContactAudrey Witko
CorrespondentAudrey Witko
HUNTLEIGH TECHNOLOGY, INC. 227 RTE. 33 EAST Manalapan,  NJ  07726
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-25
Decision Date1997-02-21

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