OBSTETRIC PULSAR TWO CHANNEL TENS

Stimulator, Nerve, Transcutaneous, For Pain Relief

SPEMBLY MEDICAL LTD.

The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Obstetric Pulsar Two Channel Tens.

Pre-market Notification Details

Device IDK840497
510k NumberK840497
Device Name:OBSTETRIC PULSAR TWO CHANNEL TENS
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant SPEMBLY MEDICAL LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-06
Decision Date1984-04-16

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