510(k) K993951
K993951 is an FDA 510(k) premarket notification submitted by Chek-Med Systems for the device "SPOT ENDOSCOPIC MARKER". The FDA issued a decision of Substantially Equivalent on February 18, 2000. The device falls under product code NBG (Marker, Colon), a Class II device regulated under 21 CFR 876.1500. Chek-Med Systems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2000
- Date Received
- November 22, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Colon
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type