DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE

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 13l40 St. Marks's Pudendal Electrode.

Pre-market Notification Details

Device IDK874758
510k NumberK874758
Device Name:DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale,  NJ  07401
ContactHenrik Henriksen
CorrespondentHenrik Henriksen
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 Received1987-11-18
Decision Date1988-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05704736005852 K874758 000

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