510(k) K213760
K213760 is an FDA 510(k) premarket notification submitted by HeartLung Corporation for the device "ABMD Software". The FDA issued a decision of Substantially Equivalent on July 29, 2022. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. HeartLung Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2022
- Date Received
- December 1, 2021
- 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