The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Sonoranger Transvaginal Probe.
| Device ID | K862627 |
| 510k Number | K862627 |
| Device Name: | SONORANGER TRANSVAGINAL PROBE |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William C Nealon |
| Correspondent | William C Nealon AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-10 |
| Decision Date | 1986-08-01 |