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FDA 510(k)

Smart Kit Basic, Smart Kit Pro

K-Number: K202443 · 2021-03-11

ApplicantBsl Co., Ltd.
Decision Date2021-03-11
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Smart Kit Basic, Smart Kit Pro is the device name listed in this FDA 510(k) record. The listed applicant is Bsl Co., Ltd.. It received FDA 510(k) clearance on 2021-03-11 under 510(k) 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. The listed applicant is Bsl Co., Ltd.. The 510(k) number is K202443.

When did Smart Kit Basic, Smart Kit Pro receive FDA 510(k) clearance?

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

Who is the listed applicant for Smart Kit Basic, Smart Kit Pro?

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

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.

Other records listing Bsl Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172717Automatic Tissue Processing Unit

Related Devices (Code: MUU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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