The following data is part of a premarket notification filed by Meditrina, Inc. with the FDA for Aveta System.
| Device ID | K191958 |
| 510k Number | K191958 |
| Device Name: | Aveta System |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Meditrina, Inc. 1190 Saratoga Avenue, Suite 180 San Jose, CA 95129 |
| Contact | Csaba Truckai |
| Correspondent | Csaba Truckai Meditrina, Inc. 1190 Saratoga Avenue, Suite 180 San Jose, CA 95129 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-23 |
| Decision Date | 2019-10-01 |