510(k) K861163
K861163 is an FDA 510(k) premarket notification submitted by Xtal Corp. for the device "XTAL X-800 SHADOWGRAPH". The FDA issued a decision of Substantially Equivalent on May 6, 1986. Xtal Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1986
- Date Received
- March 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No