QBioScan
by Medeia, Inc.
510(k) K150804
QBioScan is a Class II device made by Medeia, Inc., cleared under FDA 510(k) K150804 on 19 Oct 2015, 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 | NumberK150804 | Date19 Oct 2015 | StatusActive |
Official records
- FDA 510(k) database K150804
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1540
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K150804
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 | |||
|---|---|---|---|---|
| SudoCheck HW4 | HW4 | 08690020003024 | — | On the market |
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