Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Promisemed Heel Blood Lancet

K-Number: K193009 · 2019-12-03

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2019-12-03
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Promisemed Heel Blood Lancet is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2019-12-03 under approval number K193009. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Promisemed Heel Blood Lancet?

Promisemed Heel Blood Lancet is a medical device that received FDA 510(k) clearance on 2019-12-03. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K193009.

When was Promisemed Heel Blood Lancet approved by the FDA?

Promisemed Heel Blood Lancet received FDA 510(k) clearance on 2019-12-03, under approval number K193009.

What company makes Promisemed Heel Blood Lancet?

Promisemed Heel Blood Lancet is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Promisemed Heel Blood Lancet?

The FDA product code for Promisemed Heel Blood Lancet is FMK.

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle K211890Promisemed Sharps container

View all 35 devices →

Related Devices (Code: FMK)

K153670Genteel Lancing DeviceGenteel, LLC K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsBecton, Dickinson and Company K222408Disposable Safety LancetBeijing Ruicheng Medical Supplies Co., Ltd.

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.

↑