The following data is part of a premarket notification filed by General Devices with the FDA for Gemscom Series 3000.
Device ID | K914889 |
510k Number | K914889 |
Device Name: | GEMSCOM SERIES 3000 |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
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 | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-31 |
Decision Date | 1992-03-04 |