BlueDop Vascular Expert— 510(k) K260700
Substantially EquivalentBlueDop Medical, Ltd.
FDA 510(k) clearance K260700 for BlueDop Vascular Expert, Substantially Equivalent on 2026-07-08. Applicant: BlueDop Medical, Ltd.. Device class: 2.
Summary
BlueDop Medical's BlueDop Vascular Expert is filed under DPW, cardiovascular blood flowmeters. The record doesn't describe the device's components or outputs.
Class II, 21 CFR 870.2100. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).
BlueDop Medical filed from London, United Kingdom. Review took 126 calendar days (March 4 to July 8, 2026).
Clearance details
- Applicant
- BlueDop Medical, Ltd.
- Product code
- Product code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, GB
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Data sourced from openFDA. This site is unofficial and independent of the FDA.