The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Alpha Mc-9s Mobil C-arm Image Intensifier Unit.
| Device ID | K883372 |
| 510k Number | K883372 |
| Device Name: | ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| 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 | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-10 |
| Decision Date | 1988-11-25 |