The following data is part of a premarket notification filed by Mirada Medical Ltd. with the FDA for Simplicit90y.
Device ID | K182016 |
510k Number | K182016 |
Device Name: | Simplicit90Y |
Classification | System, Image Processing, Radiological |
Applicant | Mirada Medical Ltd. Oxford Center For Innovation, New Road Oxford, GB Ox1 1by |
Contact | Sarah Bond |
Correspondent | Sarah Bond Mirada Medical Ltd. Oxford Center For Innovation, New Road Oxford, GB Ox1 1by |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-27 |
Decision Date | 2018-12-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B334SY2P00 | K182016 | 000 |
B334SY2P20 | K182016 | 000 |
B334SY2P40 | K182016 | 000 |
B334SY2P60 | K182016 | 000 |
B334SY2P10 | K182016 | 000 |
B334SY2P120 | K182016 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SIMPLICIT90Y 88232299 not registered Live/Pending |
Biocompatibles UK Limited 2018-12-17 |