The following data is part of a premarket notification filed by Flight Medical Innovations Ltd. with the FDA for Flight 60 Ventilator.
| Device ID | K111683 |
| 510k Number | K111683 |
| Device Name: | FLIGHT 60 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | FLIGHT MEDICAL INNOVATIONS LTD. 1914 JN PEASE PLACE Charlotte, NC 28262 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman FLIGHT MEDICAL INNOVATIONS LTD. 1914 JN PEASE PLACE Charlotte, NC 28262 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-15 |
| Decision Date | 2011-10-31 |
| Summary: | summary |