The following data is part of a premarket notification filed by General Devices with the FDA for Rosetta-lt/rosetta-rx.
Device ID | K002089 |
510k Number | K002089 |
Device Name: | ROSETTA-LT/ROSETTA-RX |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | GENERAL DEVICES 1000 RIVER ST. Ridgefield, NJ 07657 |
Contact | Michael Smith |
Correspondent | Michael Smith GENERAL DEVICES 1000 RIVER ST. Ridgefield, NJ 07657 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-11 |
Decision Date | 2000-11-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00862186000386 | K002089 | 000 |