Aerosure Medic
by Actegy, Ltd.
510(k) K140772
Aerosure Medic is a Class II device made by Actegy, Ltd., cleared under FDA 510(k) K140772 on 19 Dec 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 | NumberK140772 | Date19 Dec 2014 | StatusActive |
Official records
- FDA 510(k) database K140772
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BWF
- FDA applicant
- Actegy , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5690
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K140772
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 | |||
|---|---|---|---|---|
| Aerosure 3481AJ | 1474 / 3481AJ | 00858058005047 | — | On the market |
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