ENDOSCOUT
System, Nuclear Magnetic Resonance Imaging
ROBIN MEDICAL, INC.
The following data is part of a premarket notification filed by Robin Medical, Inc. with the FDA for Endoscout.
Pre-market Notification Details
| Device ID | K033485 |
| 510k Number | K033485 |
| Device Name: | ENDOSCOUT |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ROBIN MEDICAL, INC. MIZPE AVIV INDUSTRIAL PARK 13 M.p. Misgav, IL 20187 |
| Contact | Benny Arazy |
| Correspondent | Benny Arazy ROBIN MEDICAL, INC. MIZPE AVIV INDUSTRIAL PARK 13 M.p. Misgav, IL 20187 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-04 |
| Decision Date | 2004-04-20 |
Trademark Results [ENDOSCOUT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOSCOUT 78082857 3013729 Dead/Cancelled |
Robin Medical, Inc. 2001-09-06 |
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