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 |