The following data is part of a premarket notification filed by Flight Medical Innovations Ltd. with the FDA for Flight 60 Ventilator.
| Device ID | K143035 |
| 510k Number | K143035 |
| Device Name: | Flight 60 Ventilator |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | FLIGHT MEDICAL INNOVATIONS LTD. 13 HAMELACHA STREET NORTH INDUSTRIAL PARK Lod, IL 71520 |
| Contact | Yanir Shaked |
| Correspondent | Bosmat Friedman MJRAC 1208-12 Rockford Rd, Toronto, CA M2r 3a2 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-22 |
| Decision Date | 2016-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290013641974 | K143035 | 000 |
| 17290013641967 | K143035 | 000 |
| 17290013641950 | K143035 | 000 |
| 17290013641943 | K143035 | 000 |
| 17290013641936 | K143035 | 000 |
| 17290013641929 | K143035 | 000 |