The following data is part of a premarket notification filed by General Devices with the FDA for Gemscom Series 3000.
| Device ID | K914889 |
| 510k Number | K914889 |
| Device Name: | GEMSCOM SERIES 3000 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | GENERAL DEVICES 190 LEONIA AVE. Bogota, NJ 07603 |
| Contact | Michael Smith |
| Correspondent | Michael Smith GENERAL DEVICES 190 LEONIA AVE. Bogota, NJ 07603 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-31 |
| Decision Date | 1992-03-04 |