The following data is part of a premarket notification filed by Meditrina, Inc. with the FDA for Aveta System.
| Device ID | K190372 |
| 510k Number | K190372 |
| Device Name: | Aveta System |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Meditrina, Inc. 1601 S. De Anza Blvd, Suite 165 Cupertino, CA 95014 |
| Contact | Csaba Truckai |
| Correspondent | Csaba Truckai Meditrina, Inc. 1601 S. De Anza Blvd, Suite 165 Cupertino, CA 95014 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2019-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850006759071 | K190372 | 000 |
| 00850006759293 | K190372 | 000 |
| 00850006759286 | K190372 | 000 |
| 00850006759354 | K190372 | 000 |
| 00850006759330 | K190372 | 000 |
| 00850006759392 | K190372 | 000 |
| 00850006759378 | K190372 | 000 |
| 00850006759552 | K190372 | 000 |
| 00850006759583 | K190372 | 000 |
| 00850006759576 | K190372 | 000 |
| 00850006759606 | K190372 | 000 |
| 00850006759248 | K190372 | 000 |
| 00850006759262 | K190372 | 000 |
| 00850006759156 | K190372 | 000 |
| 00850006759064 | K190372 | 000 |
| 00850006759057 | K190372 | 000 |
| 00850006759217 | K190372 | 000 |
| 00850006759200 | K190372 | 000 |
| 00850006759194 | K190372 | 000 |
| 00850006759187 | K190372 | 000 |
| 00850006759002 | K190372 | 000 |
| 00850006759040 | K190372 | 000 |
| 00850006759033 | K190372 | 000 |
| 00850006759019 | K190372 | 000 |
| 00850006759224 | K190372 | 000 |