iovera system— 510(k) K161835
Substantially EquivalentMyoscience, Inc.
FDA 510(k) clearance K161835 for iovera system, Substantially Equivalent on 2017-03-24. Applicant: Myoscience, Inc..
Clearance details
- Applicant
- Myoscience, Inc.
- Product code
- Code GXH
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.