The following data is part of a premarket notification filed by General Devices with the FDA for Gemscom Series 5000,.
| Device ID | K935839 |
| 510k Number | K935839 |
| Device Name: | GEMSCOM SERIES 5000, |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| 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 | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-07 |
| Decision Date | 1994-11-10 |