Promisemed Insulin Pen Needle
K-Number: K210059 · 2021-07-21
Device Summary
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. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K210059.
When did Promisemed Insulin Pen Needle receive FDA 510(k) clearance?
Promisemed Insulin Pen Needle received FDA 510(k) clearance on 2021-07-21, under 510(k) number K210059.
Who is the listed applicant for Promisemed Insulin Pen 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 Promisemed Insulin Pen Needle?
The FDA product code for Promisemed Insulin Pen Needle is FMI.
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.
Related Devices (Code: FMI)
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.