The following data is part of a premarket notification filed by Mobius Imaging, Llc with the FDA for Airo Ct System.
Device ID | K131431 |
510k Number | K131431 |
Device Name: | AIRO CT SYSTEM |
Classification | System, X-ray, Tomography, Computed |
Applicant | MOBIUS IMAGING, LLC 323 WEST MAIN STREET Ayer, MA 01432 |
Contact | Norma Lemay |
Correspondent | Norma Lemay MOBIUS IMAGING, LLC 323 WEST MAIN STREET Ayer, MA 01432 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-17 |
Decision Date | 2013-09-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00869346000200 | K131431 | 000 |