FDA 510(k)

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

K-Nummer: K211001 · 2021-05-20

AntragstellerMedtec, Inc. Dba Civco Medical Solutions and Civco

Entscheidungsdatum2021-05-20

ProduktcodeIYE

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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