The following data is part of a premarket notification filed by Flight Medical Innovations Ltd. with the FDA for Flight 60 Ventilator.
| Device ID | K130171 |
| 510k Number | K130171 |
| 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 | 2013-01-24 |
| Decision Date | 2014-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290013641387 | K130171 | 000 |
| 17290013641363 | K130171 | 000 |
| 17290013641264 | K130171 | 000 |
| 17290013641257 | K130171 | 000 |
| 17290013641110 | K130171 | 000 |
| 17290013641103 | K130171 | 000 |
| 17290013641073 | K130171 | 000 |
| 17290013641066 | K130171 | 000 |