The following data is part of a premarket notification filed by General Devices with the FDA for Prep-check.
| Device ID | K830876 |
| 510k Number | K830876 |
| Device Name: | PREP-CHECK |
| Classification | Tester, Electrode, Surface, Electrocardiographic |
| Applicant | GENERAL DEVICES 86 HARRIET AVE. Bergenfield, NJ 07621 |
| Contact | Michael Smith |
| Correspondent | Michael Smith GENERAL DEVICES 86 HARRIET AVE. Bergenfield, NJ 07621 |
| Product Code | KRC |
| CFR Regulation Number | 870.2370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-18 |
| Decision Date | 1983-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862186000317 | K830876 | 000 |
| 00862186000300 | K830876 | 000 |