MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP

Monitor, Pressure, Intrauterine

SPECTRAMED, INC.

The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Model Dt-iupc2 Transducer Tipped Dual Lumen Iup.

Pre-market Notification Details

Device IDK894362
510k NumberK894362
Device Name:MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP
ClassificationMonitor, Pressure, Intrauterine
Applicant SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
ContactRobert L Leavitt
CorrespondentRobert L Leavitt
SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
Product CodeKXO  
CFR Regulation Number884.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-14
Decision Date1989-08-15

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