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FDA 510(k)

Verifine® Ease Lancing Device, Verifine® Lancing Device

K-Number: K223643 · 2023-02-21

Decision Date2023-02-21
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Verifine® Ease Lancing Device, Verifine® Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2023-02-21 under 510(k) number K223643. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Verifine® Ease Lancing Device, Verifine® Lancing Device?

Verifine® Ease Lancing Device, Verifine® Lancing Device is a medical device that received FDA 510(k) clearance on 2023-02-21. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K223643.

When did Verifine® Ease Lancing Device, Verifine® Lancing Device receive FDA 510(k) clearance?

Verifine® Ease Lancing Device, Verifine® Lancing Device received FDA 510(k) clearance on 2023-02-21, under 510(k) number K223643.

Who is the listed applicant for Verifine® Ease Lancing Device, Verifine® Lancing Device?

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

What is the FDA product code for Verifine® Ease Lancing Device, Verifine® Lancing Device?

The FDA product code for Verifine® Ease Lancing Device, Verifine® Lancing Device is QRL.

Other records listing Promisemed Hangzhou Meditech 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.

View all 35 devices →

Related Devices (Code: QRL)

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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