510(k) K221195
K221195 is an FDA 510(k) premarket notification submitted by Active Life Scientific, Inc. for the device "OsteoProbe". The FDA issued a decision of Substantially Equivalent on June 28, 2022. The device falls under product code QGQ (Bone Indentation Device), a Class II device regulated under 21 CFR 888.1600. Active Life Scientific, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2022
- Date Received
- April 25, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Indentation Device
- Device Class
- Class II
- Regulation Number
- 888.1600
- Review Panel
- OR
- Submission Type
A bone indentation device is a device that measures resistance to indentation in bone.