The following data is part of a premarket notification filed by Rebound Therapeutics with the FDA for Aurora Surgiscope System (surgiscope), Aurora Surgiscope System (image Control Box).
| Device ID | K201840 |
| 510k Number | K201840 |
| Device Name: | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) |
| Classification | Endoscope, Neurological |
| Applicant | Rebound Therapeutics 13900 Alton Parkway Suite 120 Irvine, CA 92618 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong Rebound Therapeutics 13900 Alton Parkway Suite 120 Irvine, CA 92618 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2020-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002332261 | K201840 | 000 |
| 00850002332254 | K201840 | 000 |
| 00850002332247 | K201840 | 000 |
| 00850002332049 | K201840 | 000 |