The following data is part of a premarket notification filed by General Devices with the FDA for Gemscom Series 300 12-lead Ecg (12-lead Option).
| Device ID | K921929 |
| 510k Number | K921929 |
| Device Name: | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| 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 | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-24 |
| Decision Date | 1992-09-18 |