FDA 510(k)

헬스비콘 HB2 쇼츠뱅크

K-번호: K172719 · 2018-05-11

결정일2018-05-11

제품 코드MMK

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

HealthBeacon HB2 Sharps Bin is the device name listed in this FDA 510(k) record. The listed applicant is Healthbeacon, Ltd.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K172719. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HealthBeacon HB2 Sharps Bin?

HealthBeacon HB2 Sharps Bin is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Healthbeacon, Ltd.. The 510(k) number is K172719.

When did HealthBeacon HB2 Sharps Bin receive FDA 510(k) clearance?

HealthBeacon HB2 Sharps Bin received FDA 510(k) clearance on 2018-05-11, under 510(k) number K172719.

Who is the listed applicant for HealthBeacon HB2 Sharps Bin?

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

What is the FDA product code for HealthBeacon HB2 Sharps Bin?

The FDA product code for HealthBeacon HB2 Sharps Bin is MMK.

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헬스비콘 HB2 쇼츠뱅크

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MMK)

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