510(k) K182880
K182880 is an FDA 510(k) premarket notification submitted by Halifax Biomedical, Inc. for the device "Halifax Imaging Kit". The FDA issued a decision of Substantially Equivalent on Oct 31, 2018. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Halifax Biomedical, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 31, 2018
- Date Received
- Oct 15, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)