The following data is part of a premarket notification filed by Emblation Ltd with the FDA for Swift System.
| Device ID | K181941 |
| 510k Number | K181941 |
| Device Name: | Swift System |
| Classification | System, Ablation, Microwave And Accessories |
| Applicant | Emblation Ltd Forrester Lodge Alloa, GB Fk10 2hu |
| Contact | Mairi Macfadyen |
| Correspondent | Mairi Macfadyen Emblation Ltd Forrester Lodge Alloa, GB Fk10 2hu |
| Product Code | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-20 |
| Decision Date | 2018-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060652910046 | K181941 | 000 |
| 05060652910039 | K181941 | 000 |
| 05060652910022 | K181941 | 000 |
| 05060652910015 | K181941 | 000 |
| 05060652910008 | K181941 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SWIFT SYSTEM 73434415 not registered Dead/Abandoned |
HARBOR FEDERAL SAVINGS AND LOAN ASSOCIATION 1983-07-13 |