The following data is part of a premarket notification filed by Flight Medical Innovations Ltd. with the FDA for Flight 60 Ventilator.
| Device ID | K120726 |
| 510k Number | K120726 |
| Device Name: | FLIGHT 60 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | FLIGHT MEDICAL INNOVATIONS LTD. 1914 JN PEASE PLACE Charlotte, NC 28262 |
| Contact | Choshana Friedman |
| Correspondent | Choshana 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 | 2012-03-09 |
| Decision Date | 2012-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290013641998 | K120726 | 000 |
| 17290013641271 | K120726 | 000 |
| 17290013641233 | K120726 | 000 |
| 17290013641202 | K120726 | 000 |
| 17290013641189 | K120726 | 000 |
| 17290013641158 | K120726 | 000 |
| 17290013641141 | K120726 | 000 |
| 17290013641134 | K120726 | 000 |
| 17290013641080 | K120726 | 000 |
| 17290013641035 | K120726 | 000 |
| 17290013641288 | K120726 | 000 |
| 17290013641585 | K120726 | 000 |
| 17290013641981 | K120726 | 000 |
| 17290013641899 | K120726 | 000 |
| 17290013641882 | K120726 | 000 |
| 17290013641875 | K120726 | 000 |
| 17290013641806 | K120726 | 000 |
| 17290013641721 | K120726 | 000 |
| 17290013641707 | K120726 | 000 |
| 17290013641691 | K120726 | 000 |
| 17290013641608 | K120726 | 000 |
| 17290013641028 | K120726 | 000 |