Spirobank Oxi— 510(k) K230501
Substantially EquivalentMir Medical International Research USA
FDA 510(k) clearance K230501 for Spirobank Oxi, Substantially Equivalent on 2023-12-15. Applicant: Mir Medical International Research USA. Device class: 2.
Clearance details
- Applicant
- Mir Medical International Research USA
- Product code
- Code BZG
- Device class
- Class 2
- Regulation
- 21 CFR 868.1840
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Berlin, WI, US
Recent devices under product code BZG
view allData sourced from openFDA. This site is unofficial and independent of the FDA.