The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Resubmittal Of Mi 1000c Microimager.
| Device ID | K881979 |
| 510k Number | K881979 |
| Device Name: | RESUBMITTAL OF MI 1000C MICROIMAGER |
| Classification | Transducer, 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 | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-12 |
| Decision Date | 1989-06-12 |