iovera system— 510(k) K173763
Substantially EquivalentMyoscience, Inc.
FDA 510(k) clearance K173763 for iovera system, Substantially Equivalent on 2018-02-28. Applicant: Myoscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Myoscience, Inc.
- Product code
- Code GXH
- Device class
- Class 2
- Regulation
- 21 CFR 882.4250
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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