PRO2ELITE-1
PRO2ELITE-1 is a Class II device made by Salter Labs, LLC, cleared under FDA 510(k) K983500 on 17 Mar 1999 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00607411918964), active as of 23 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 | Number00607411918964 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK983500 | Date17 Mar 1999 | StatusActive |
Official records
- AccessGUDID record 00607411918964
- FDA 510(k) database K983500
Across registries
- FDA 510(k) K983500 decided 17 Mar 1999 Active
- FDA GUDID UDI-DI 00607411918964 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K983500
- Listed FDA GUDID 00607411918964
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Respiratory oxygen monitor, battery-powered
- Model / Ref / Catalog
- PRO2ELITE-1
- Primary DI / UDI-DI
- 00607411918964
- 510(k) Number
- FDA product code
- CCL
- GMDN term
- Respiratory oxygen monitor, battery-powered
- Device class
- Class II
- Regulation number
- 868.1720
- GUDID distribution status
- In Commercial Distribution
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