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FDA 510(k)

Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes

K-Number: K211242 · 2021-09-09

Decision Date2021-09-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes 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 2021-09-09 under 510(k) number K211242. 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 Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes?

Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K211242.

When did Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes receive FDA 510(k) clearance?

Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes received FDA 510(k) clearance on 2021-09-09, under 510(k) number K211242.

Who is the listed applicant for Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes?

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 Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes?

The FDA product code for Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes 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.