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FDA 510(k)

Verifine Safety Syringe with Fixed Needle

K-Number: K213560 · 2022-04-05

Decision Date2022-04-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Verifine Safety Syringe with Fixed Needle 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 2022-04-05 under 510(k) number K213560. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Verifine Safety Syringe with Fixed Needle?

Verifine Safety Syringe with Fixed Needle is a medical device that received FDA 510(k) clearance on 2022-04-05. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K213560.

When did Verifine Safety Syringe with Fixed Needle receive FDA 510(k) clearance?

Verifine Safety Syringe with Fixed Needle received FDA 510(k) clearance on 2022-04-05, under 510(k) number K213560.

Who is the listed applicant for Verifine Safety Syringe with Fixed Needle?

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 Safety Syringe with Fixed Needle?

The FDA product code for Verifine Safety Syringe with Fixed Needle is FMF.

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: FMF)

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