510(k) K232674
K232674 is an FDA 510(k) premarket notification submitted by Nuance Medical, LLC for the device "PainFreeze II". The FDA issued a decision of Substantially Equivalent on February 12, 2024. The device falls under product code MLY (Vapocoolant Device), a Class U device. Nuance Medical, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2024
- Date Received
- September 1, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vapocoolant Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type