The following data is part of a premarket notification filed by General Devices with the FDA for Eim-107 Prep-check.
Device ID | K993202 |
510k Number | K993202 |
Device Name: | EIM-107 PREP-CHECK |
Classification | Device, Galvanic Skin Response Measurement |
Applicant | GENERAL DEVICES 1000 RIVER ST. Ridgefield, NJ 07657 |
Contact | Michael Smith |
Correspondent | Michael Smith GENERAL DEVICES 1000 RIVER ST. Ridgefield, NJ 07657 |
Product Code | GZO |
CFR Regulation Number | 882.1540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-24 |
Decision Date | 1999-12-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00086186000331 | K993202 | 000 |
00862186000362 | K993202 | 000 |
00862186000355 | K993202 | 000 |
00862186000348 | K993202 | 000 |
00862186000324 | K993202 | 000 |
00862186000331 | K993202 | 000 |