Respiration Rate algorithm
FDA 510(k) clearance K251326 · decided 2026-06-11
Clearance details
- K-number
- K251326
- Device name
- Respiration Rate algorithm
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-04-29
- Decision date
- 2026-06-11
- Days to decision
- 408 days
- Clearance type
- Traditional
- Product code
- BZQ
- Device class
- 2
- Regulation number
- 868.2375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.