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FDA 510(k)

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner

K-Number: K211001 · 2021-05-20

ApplicantMedtec, Inc. Dba Civco Medical Solutions and Civco
Decision Date2021-05-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc. Dba Civco Medical Solutions and Civco. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K211001. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner?

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Medtec, Inc. Dba Civco Medical Solutions and Civco. The 510(k) number is K211001.

When did C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner receive FDA 510(k) clearance?

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner received FDA 510(k) clearance on 2021-05-20, under 510(k) number K211001.

Who is the listed applicant for C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner?

The FDA 510(k) record lists Medtec, Inc. Dba Civco Medical Solutions and Civco as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner?

The FDA product code for C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner is IYE.

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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