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 |