FDA 510(k)

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

K-Number: K161950 · 2017-05-11

ApplicantPromisemed Hangzhou Meditech Co., Ltd.

Decision Date2017-05-11

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2017-05-11 under approval number K161950. 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 Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle?

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K161950.

When was Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle approved by the FDA?

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle received FDA 510(k) clearance on 2017-05-11, under approval number K161950.

What company makes Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle?

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

What is the FDA product code for Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle?

The FDA product code for Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle is FMI.

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Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

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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.