The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Apa-c Catalog Number A-8001-c.
| Device ID | K884299 |
| 510k Number | K884299 |
| Device Name: | APA-C CATALOG NUMBER A-8001-C |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-13 |
| Decision Date | 1989-01-10 |