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FDA 510(k)

6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF

K-Number: K212105 · 2021-08-23

ApplicantPzmedical Technology Co., Ltd.
Decision Date2021-08-23
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF is a medical device manufactured by Pzmedical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-23 under approval number K212105. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF?

6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF is a medical device that received FDA 510(k) clearance on 2021-08-23. It is manufactured by Pzmedical Technology Co., Ltd.. The 510(k) number is K212105.

When was 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF approved by the FDA?

6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF received FDA 510(k) clearance on 2021-08-23, under approval number K212105.

What company makes 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF?

6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF is manufactured by Pzmedical Technology Co., Ltd..

What is the FDA product code for 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF?

The FDA product code for 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF is MQB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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