DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER

Cystometric Gas (carbon-dioxide) On Hydraulic Device

DANTEC ELECTRONICS, INC.

The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Dantec 22k60/61/62 Catheter Tip Transducer.

Pre-market Notification Details

Device IDK884915
510k NumberK884915
Device Name:DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale,  NJ  07401
ContactT Quigley
CorrespondentT Quigley
DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale,  NJ  07401
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-28
Decision Date1989-10-04

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