The following data is part of a premarket notification filed by General Devices with the FDA for Dr-2c (modification).
Device ID | K862596 |
510k Number | K862596 |
Device Name: | DR-2C (MODIFICATION) |
Classification | Recorder, Paper Chart |
Applicant | GENERAL DEVICES 86 HARRIET AVE. Bergenfield, NJ 07621 |
Contact | Michael Smith |
Correspondent | Michael Smith GENERAL DEVICES 86 HARRIET AVE. Bergenfield, NJ 07621 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-27 |
Decision Date | 1986-09-26 |