The following data is part of a premarket notification filed by Fx-2 with the FDA for Fx-2p Nms (2 Channel Portable).
Device ID | K945508 |
510k Number | K945508 |
Device Name: | FX-2P NMS (2 CHANNEL PORTABLE) |
Classification | Stimulator, Muscle, Powered |
Applicant | FX-2 616 VINEYARD PT. Guilford, CT 06437 |
Contact | Mark Heller |
Correspondent | Mark Heller FX-2 616 VINEYARD PT. Guilford, CT 06437 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-09 |
Decision Date | 1995-05-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858703006115 | K945508 | 000 |
00858703006092 | K945508 | 000 |