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 |