The following data is part of a premarket notification filed by Flight Medical Ltd. with the FDA for Flight 60 Ventilator, Model F-60.
| Device ID | K100753 |
| 510k Number | K100753 |
| Device Name: | FLIGHT 60 VENTILATOR, MODEL F-60 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | FLIGHT MEDICAL LTD. 1914 JN PEASE PL Charlotte, NC 28262 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman FLIGHT MEDICAL LTD. 1914 JN PEASE PL 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 | 2010-03-17 |
| Decision Date | 2010-08-20 |
| Summary: | summary |