510(k) K230501
K230501 is an FDA 510(k) premarket notification submitted by Mir Medical International Research USA for the device "Spirobank Oxi". The FDA issued a decision of Substantially Equivalent on December 15, 2023. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2023
- Date Received
- February 24, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type