6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF— 510(k) K212105

Name: FDA 510(k) clearance K212105
Creator: U.S. Food and Drug Administration
Published: 2021-08-23

Substantially Equivalent

Pzmedical Technology Co., Ltd.

FDA 510(k) clearance K212105 for 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF, Substantially Equivalent on 2021-08-23. Applicant: Pzmedical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Pzmedical Technology Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2021-07-06
Decision date: 2021-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.