EIM-107 PREP-CHECK

Device, Galvanic Skin Response Measurement

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Eim-107 Prep-check.

Pre-market Notification Details

Device IDK993202
510k NumberK993202
Device Name:EIM-107 PREP-CHECK
ClassificationDevice, Galvanic Skin Response Measurement
Applicant GENERAL DEVICES 1000 RIVER ST. Ridgefield,  NJ  07657
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 1000 RIVER ST. Ridgefield,  NJ  07657
Product CodeGZO  
CFR Regulation Number882.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-24
Decision Date1999-12-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00086186000331 K993202 000
00862186000362 K993202 000
00862186000355 K993202 000
00862186000348 K993202 000
00862186000324 K993202 000
00862186000331 K993202 000

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