The following data is part of a premarket notification filed by Airs Medical Inc. with the FDA for Swiftmr.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800124700006 | K220416 | 000 |
08800124700075 | K220416 | 000 |
08800124700099 | K220416 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SWIFTMR 90467611 not registered Live/Pending |
Airs medical Inc. 2021-01-14 |