The following data is part of a premarket notification filed by Robin Medical, Inc. with the FDA for Endoscout Tracking System.
| Device ID | K111226 |
| 510k Number | K111226 |
| Device Name: | ENDOSCOUT TRACKING SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ROBIN MEDICAL, INC. 56B SHADOWBROOK DRIVE Hudson, NH 03051 |
| Contact | Raymond Kelly |
| Correspondent | Raymond Kelly ROBIN MEDICAL, INC. 56B SHADOWBROOK DRIVE Hudson, NH 03051 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-07-01 |