Respiration Rate algorithm— 510(k) K251326
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K251326 for Respiration Rate algorithm, Substantially Equivalent on 2026-06-11. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code BZQ
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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