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FDA 510(k)

L1-PRO SYSTEM

K-Number: K041665 · 2004-07-23

ApplicantPelikan Technologies, Inc.
Decision Date2004-07-23
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

L1-PRO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pelikan Technologies, Inc.. It received FDA 510(k) clearance on 2004-07-23 under 510(k) number K041665. 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 L1-PRO SYSTEM?

L1-PRO SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Pelikan Technologies, Inc.. The 510(k) number is K041665.

When did L1-PRO SYSTEM receive FDA 510(k) clearance?

L1-PRO SYSTEM received FDA 510(k) clearance on 2004-07-23, under 510(k) number K041665.

Who is the listed applicant for L1-PRO SYSTEM?

The FDA 510(k) record lists Pelikan Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for L1-PRO SYSTEM?

The FDA product code for L1-PRO SYSTEM is FMK.

Related Clinical Trials

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.

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Other records listing Pelikan Technologies, Inc. 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.

K024170L1 SYSTEM

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.

K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.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.

Official Source

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

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