The following data is part of a premarket notification filed by General Devices with the FDA for Tru-view Multi-channel Display.
| Device ID | K912008 |
| 510k Number | K912008 |
| Device Name: | TRU-VIEW MULTI-CHANNEL DISPLAY |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-06 |
| Decision Date | 1991-10-09 |