FDA 510(k)

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K-번호: K230548 · 2024-02-02

결정일2024-02-02

제품 코드MQC

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기기 요약

Myoaligner Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Myohealth Technologies, LLC. It received FDA 510(k) clearance on 2024-02-02 under 510(k) number K230548. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Myoaligner Appliance?

Myoaligner Appliance is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Myohealth Technologies, LLC. The 510(k) number is K230548.

When did Myoaligner Appliance receive FDA 510(k) clearance?

Myoaligner Appliance received FDA 510(k) clearance on 2024-02-02, under 510(k) number K230548.

Who is the listed applicant for Myoaligner Appliance?

The FDA 510(k) record lists Myohealth Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myoaligner Appliance?

The FDA product code for Myoaligner Appliance is MQC.

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관련 임상시험

관련 기기 (코드: MQC)

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