The following data is part of a premarket notification filed by Selectivemed Components Inc. with the FDA for Guardian Dysphagia Dual Channel Nmes Unit.
Device ID | K120922 |
510k Number | K120922 |
Device Name: | GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT |
Classification | Stimulator, Muscle, Powered |
Applicant | SELECTIVEMED COMPONENTS INC. 8870 RAVELLO CT Naples, FL 34114 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm SELECTIVEMED COMPONENTS INC. 8870 RAVELLO CT Naples, FL 34114 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-27 |
Decision Date | 2013-02-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B736465731 | K120922 | 000 |