510(k) K242295
K242295 is an FDA 510(k) premarket notification submitted by BunkerHill Health for the device "BunkerHill BMD". The FDA issued a decision of Substantially Equivalent on April 8, 2025. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. BunkerHill Health has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2025
- Date Received
- August 2, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Densitometer, Bone
- Device Class
- Class II
- Regulation Number
- 892.1170
- Review Panel
- RA
- Submission Type