Clearance Summary
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT received FDA 510(k) clearance under submission number K120922, sponsored by Selectivemed Components, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2013-02-07.
- Submission: K120922
- Applicant / Sponsor: Selectivemed Components, Inc.
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2013-02-07
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.