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FDA 510(k)

Lancet

K-Number: K221839 · 2022-09-19

Decision Date2022-09-19
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Xinle Sci&Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-09-19 under 510(k) number K221839. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lancet?

Lancet is a medical device that received FDA 510(k) clearance on 2022-09-19. The listed applicant is Hebei Xinle Sci&Tech Co., Ltd.. The 510(k) number is K221839.

When did Lancet receive FDA 510(k) clearance?

Lancet received FDA 510(k) clearance on 2022-09-19, under 510(k) number K221839.

Who is the listed applicant for Lancet?

The FDA 510(k) record lists Hebei Xinle Sci&Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lancet?

The FDA product code for Lancet is FMK.

Related Devices (Code: FMK)

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.

Official Source

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