Flight 60 Ventilator
by Flight Medical Innovations Ltd 4 variants
510(k) K130171
Flight 60 Ventilator is a medical device (FDA Class II; FDA product code CBK, Ventilator, Continuous, Facility Use) made by Flight Medical Innovations Ltd, cleared under FDA 510(k) K130171 on 8 Apr 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130171 | Date8 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K130171
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CBK
- FDA applicant
- Flight Medical Innovations , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K130171
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Continuous Ventilator V100-0001-PK | V100-0001-PK | 17290013641257 | — | On the market |
| Continuous Ventilator V100-0002-PK | V100-0002-PK | 17290013641264 | — | On the market |
| Continuous Ventilator V100-0003-PK | V100-0003-PK | 17290013641387 | — | On the market |
| Continuous Ventilator V100-0004-PK | V100-0004-PK | 17290013641363 | — | On the market |
| Continuous Ventilator V60-1010 | V60-1010 | 17290013641066 | — | On the market |
| Continuous Ventilator V60-1012 | V60-1012 | 17290013641103 | — | On the market |
| Continuous Ventilator V61-1010 | V61-1010 | 17290013641073 | — | On the market |
| Continuous Ventilator V61-1012 | V61-1012 | 17290013641110 | — | On the market |
Similar devices
Other devices filed under FDA product code CBK (Ventilator, Continuous, Facility Use).
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