Iob Iob-301S
Iob Iob-301S is a Class II device made by Iob Medical, Inc., cleared under FDA 510(k) K190221 on 25 Oct 2019 and listed in FDA GUDID since 21 Mar 2022 (UDI-DI 00850035767900), 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 | GUDID listing | Number00850035767900 | Date21 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190221 | Date25 Oct 2019 | StatusActive |
Official records
- AccessGUDID record 00850035767900
- FDA 510(k) database K190221
Across registries
- FDA 510(k) K190221 decided 25 Oct 2019 Active
- FDA GUDID UDI-DI 00850035767900 listed 21 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K190221
- Listed FDA GUDID 00850035767900
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Iob
- Generic name
- Circulating-air whole-body heating system control unit
- Model / reference
- IOB-301S
- Primary DI / UDI-DI
- 00850035767900
- 510(k) Number
- FDA product code
- DWJ
- GMDN term
- Circulating-air whole-body heating system control unit
- Device class
- Class II
- Regulation number
- 870.5900
- GUDID distribution status
- In Commercial Distribution
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