The following data is part of a premarket notification filed by Chek-med Systems with the FDA for Spot Endoscopic Marker.
| Device ID | K993951 |
| 510k Number | K993951 |
| Device Name: | SPOT ENDOSCOPIC MARKER |
| Classification | Marker, Colon |
| Applicant | CHEK-MED SYSTEMS 11 PHELPS WAY P.O. BOX 289 Willington, CT 06279 |
| Contact | Rob Whalen |
| Correspondent | Rob Whalen CHEK-MED SYSTEMS 11 PHELPS WAY P.O. BOX 289 Willington, CT 06279 |
| Product Code | NBG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-22 |
| Decision Date | 2000-02-18 |