UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF +4 more— 510(k) K241746

Name: FDA 510(k) clearance K241746
Creator: U.S. Food and Drug Administration
Published: 2024-10-04

Substantially Equivalent

United Medical Resources, LLC

FDA 510(k) clearance K241746 for UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF +4 more, Substantially Equivalent on 2024-10-04. Applicant: United Medical Resources, LLC. Device class: 2.

Clearance details

Device name as filed: UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF
Applicant: United Medical Resources, LLC
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2024-06-18
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Salt Lake, UT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.