510(k) K854933
K854933 is an FDA 510(k) premarket notification submitted by Sandhill for the device "SANDHILL ELECTRONIC CALIPER". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. Sandhill has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1986
- Date Received
- December 10, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Illuminator, Radiographic-Film
- Device Class
- Class I
- Regulation Number
- 892.1890
- Review Panel
- RA
- Submission Type