510(k) K121345
K121345 is an FDA 510(k) premarket notification submitted by Halifax Biomedical, Inc. for the device "SR SUITE 1.0". The FDA issued a decision of Substantially Equivalent on Jun 1, 2012. 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
- Jun 1, 2012
- Date Received
- May 4, 2012
- Clearance Type
- Traditional
- 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)