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 | K210999 |
| 510k Number | K210999 |
| 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 | 2021-04-02 |
| Decision Date | 2021-10-14 |
Trademark Results [SwiftMR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SWIFTMR 90467611 not registered Live/Pending |
Airs medical Inc. 2021-01-14 |
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