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FDA 510(k)

Promisemed Insulin Pen Needle

K-Number: K210059 · 2021-07-21

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2021-07-21
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Promisemed Insulin Pen Needle is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2021-07-21 under approval number K210059. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Promisemed Insulin Pen Needle?

Promisemed Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2021-07-21. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K210059.

When was Promisemed Insulin Pen Needle approved by the FDA?

Promisemed Insulin Pen Needle received FDA 510(k) clearance on 2021-07-21, under approval number K210059.

What company makes Promisemed Insulin Pen Needle?

Promisemed Insulin Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Promisemed Insulin Pen Needle?

The FDA product code for Promisemed Insulin Pen Needle is FMI.

Related Clinical Trials

NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle

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Related Devices (Code: FMI)

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Official Source

View on FDA Database →

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

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