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 |