Vivatmo pro-S
FDA 510(k) clearance K243926 · decided 2025-09-11
Clearance details
- K-number
- K243926
- Device name
- Vivatmo pro-S
- Applicant
- Bosch Healthcare Solutions GmbH
- Decision
- Substantially Equivalent
- Date received
- 2024-12-20
- Decision date
- 2025-09-11
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- MXA
- Device class
- 2
- Regulation number
- 862.3080
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Waiblingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.