The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for 7.5 Mhz Bi Plane Rectal Probe (p/n: 041-815).
| Device ID | K902728 |
| 510k Number | K902728 |
| Device Name: | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William Nealon |
| Correspondent | William Nealon AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-21 |
| Decision Date | 1991-02-13 |