PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)— 510(k) K261389
Substantially EquivalentSalter Labs
FDA 510(k) clearance K261389 for PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1), Substantially Equivalent on 2026-07-30. Applicant: Salter Labs. Device class: 2.
Clearance details
- Applicant
- Salter Labs
- Product code
- Code CCL
- Device class
- Class 2
- Regulation
- 21 CFR 868.1720
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Paso, TX, US
Recent devices under product code CCL
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Adverse events under product code CCL
product code CCL- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.