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 |