EKG SPEAKS— 510(k) K032926
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K032926 for EKG SPEAKS, Substantially Equivalent on 2003-10-15. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code KRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.3640
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code KRE
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- K192296 — Medtronic 6F Taiga Guiding Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.