The following data is part of a premarket notification filed by General Devices with the FDA for Modified Dr-2c/pmc 100.
| Device ID | K896153 |
| 510k Number | K896153 |
| Device Name: | MODIFIED DR-2C/PMC 100 |
| Classification | Recorder, Magnetic Tape, Medical |
| 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 | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-24 |
| Decision Date | 1990-01-19 |