GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT— 510(k) K120922
Substantially EquivalentSelectivemed Components, Inc.
FDA 510(k) clearance K120922 for GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT, Substantially Equivalent on 2013-02-07. Applicant: Selectivemed Components, Inc.. Device class: 2.
Clearance details
- Applicant
- Selectivemed Components, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Naples, FL, US
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