SwiftMR
System, Image Processing, Radiological
AIRS Medical Inc.
The following data is part of a premarket notification filed by Airs Medical Inc. with the FDA for Swiftmr.
Pre-market Notification Details
| Device ID | K220416 |
| 510k Number | K220416 |
| Device Name: | SwiftMR |
| Classification | System, Image Processing, Radiological |
| Applicant | AIRS Medical Inc. 8-9F, CS Tower, 1838, Nambusunhwan-ro, Gwanak-gu Seoul, KR 08788 |
| Contact | Jihyeon Seo |
| Correspondent | Jihyeon Seo AIRS Medical Inc. 8-9F, CS Tower, 1838, Nambusunhwan-ro, Gwanak-gu Seoul, KR 08788 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-05-25 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800124700006 | K220416 | 000 |
| 08800124700075 | K220416 | 000 |
| 08800124700099 | K220416 | 000 |
Trademark Results [SwiftMR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SWIFTMR 90467611 not registered Live/Pending |
Airs medical Inc. 2021-01-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.