Koala
by IB Lab GmbH
510(k) K192109
Koala is a Class II device made by IB Lab GmbH, cleared under FDA 510(k) K192109 on 5 Nov 2019, 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 | NumberK192109 | Date5 Nov 2019 | StatusActive |
Official records
- FDA 510(k) database K192109
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192109
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 | |||
|---|---|---|---|---|
| KOALA V2.05 | V2.05 | 09120105730037 | — | No longer on the market |
| KOALA V2.11 | V2.11 | 09120105730464 | — | On the market |
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