Vivo 45 LS
FDA 510(k) clearance K232365 · decided 2025-12-19
Clearance details
- K-number
- K232365
- Device name
- Vivo 45 LS
- Applicant
- Oconnell Regulatory Consultants, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-07
- Decision date
- 2025-12-19
- Days to decision
- 865 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Stoneham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.