Exchange Select 150-935-000
by Aafes
Exchange Select 150-935-000 is a Class II device made by Aafes, cleared under FDA 510(k) K100488 on 22 Jul 2010 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00614299013476), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00614299013476 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100488 | Date22 Jul 2010 | StatusActive |
Official records
- AccessGUDID record 00614299013476
- FDA 510(k) database K100488
Across registries
- FDA 510(k) K100488 decided 22 Jul 2010 Active
- FDA GUDID UDI-DI 00614299013476 listed 12 Sep 2016 Listed
Recalls
-
- Terminated Z-0689-2018
Device may provide inaccurate measurements.
Timeline
- Cleared FDA 510(k) K100488
- Listed FDA GUDID 00614299013476
- Recall initiated FDA recalls Z-0689-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Exchange Select
- Generic name
- Infrared patient thermometer, skin
- Model / Ref / Catalog
- 150-935-000
- Primary DI / UDI-DI
- 00614299013476
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Infrared patient thermometer, skin
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
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