C-Qual M Breastboard; Monarch Overhead Arm Positioner— 510(k) K211001

Name: FDA 510(k) clearance K211001
Creator: U.S. Food and Drug Administration
Published: 2021-05-20

Substantially Equivalent

Medtec, Inc. Dba Civco Medical Solutions and Civco

FDA 510(k) clearance K211001 for C-Qual M Breastboard; Monarch Overhead Arm Positioner, Substantially Equivalent on 2021-05-20. Applicant: Medtec, Inc. Dba Civco Medical Solutions and Civco. Device class: 2.

Clearance details

Applicant: Medtec, Inc. Dba Civco Medical Solutions and Civco
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2021-04-02
Decision date: 2021-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange City, IA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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