The following data is part of a premarket notification filed by General Devices with the FDA for Ems Telemedicine Option (for Gems Series 4000).
| Device ID | K013533 |
| 510k Number | K013533 |
| Device Name: | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) |
| 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 | 2001-10-23 |
| Decision Date | 2002-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862186000379 | K013533 | 000 |