FDA 510(k)

XChange 장치, XChange 시스템

K-번호: K210112 · 2023-01-30

결정일2023-01-30

제품 코드CCK

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

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기기 요약

XChange Device, XChange System is the device name listed in this FDA 510(k) record. The listed applicant is Pneuma Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-01-30 under 510(k) number K210112. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the XChange Device, XChange System?

XChange Device, XChange System is a medical device that received FDA 510(k) clearance on 2023-01-30. The listed applicant is Pneuma Therapeutics, Inc.. The 510(k) number is K210112.

When did XChange Device, XChange System receive FDA 510(k) clearance?

XChange Device, XChange System received FDA 510(k) clearance on 2023-01-30, under 510(k) number K210112.

Who is the listed applicant for XChange Device, XChange System?

The FDA 510(k) record lists Pneuma Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XChange Device, XChange System?

The FDA product code for XChange Device, XChange System is CCK.

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XChange 장치, XChange 시스템

기기 요약

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관련 임상시험

관련 기기 (코드: CCK)

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