ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT— 510(k) K092202
Substantially EquivalentEswallow USA
FDA 510(k) clearance K092202 for ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT, Substantially Equivalent on 2011-02-10. Applicant: Eswallow USA. Device class: 2.
Clearance details
- Applicant
- Eswallow USA
- 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
- Traditional
- Location
- Naples, FL, US
Recent devices under product code IPF
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