FDA 510(k)

Smart Kit Basic, Smart Kit Pro

K-Number: K202443 · 2021-03-11

Decision Date2021-03-11

Product CodeMUU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Smart Kit Basic, Smart Kit Pro is a medical device manufactured by Bsl Co., Ltd.. It received FDA 510(k) clearance on 2021-03-11 under approval number K202443. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Kit Basic, Smart Kit Pro?

Smart Kit Basic, Smart Kit Pro is a medical device that received FDA 510(k) clearance on 2021-03-11. It is manufactured by Bsl Co., Ltd.. The 510(k) number is K202443.

When was Smart Kit Basic, Smart Kit Pro approved by the FDA?

Smart Kit Basic, Smart Kit Pro received FDA 510(k) clearance on 2021-03-11, under approval number K202443.

What company makes Smart Kit Basic, Smart Kit Pro?

Smart Kit Basic, Smart Kit Pro is manufactured by Bsl Co., Ltd..

What is the FDA product code for Smart Kit Basic, Smart Kit Pro?

The FDA product code for Smart Kit Basic, Smart Kit Pro is MUU.

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Official Source

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