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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 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 2019-12-03 under 510(k) 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. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K193009.

When did Promisemed Heel Blood Lancet receive FDA 510(k) clearance?

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

Who is the listed applicant for Promisemed Heel Blood Lancet?

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 Heel Blood Lancet?

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

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.

K261196Promisemed VeriEcto Automatic Biopsy NeedlesK261045Verifine Safety LancetsK254273Verisafe Safety Sterile Needles (SSN)K250192Verisafe Safety Retractable Insulin SyringesK250961Blood collection tube holdersK251138Promisemed Safety Huber Needles

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Related Devices (Code: FMK)

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.

K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.

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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