510(k) K863856
K863856 is an FDA 510(k) premarket notification submitted by Uni-Quatro Industries for the device "S-RAY CAMERA". The FDA issued a decision of Substantially Equivalent on Oct 14, 1986. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Uni-Quatro Industries has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 14, 1986
- Date Received
- Oct 2, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type
- 510(k) Exempt