VicorderCS (VCS-SYS-1100)
FDA 510(k) clearance K260693 · decided 2026-06-16
Clearance details
- K-number
- K260693
- Device name
- VicorderCS (VCS-SYS-1100)
- Applicant
- 80 Beats Medical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2026-03-03
- Decision date
- 2026-06-16
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Berlin, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.