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FDA 510(k)

LAPEX 2000

K-Number: K034009 · 2005-01-21

ApplicantMeridian Co., Ltd.
Decision Date2005-01-21
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LAPEX 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Co., Ltd.. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K034009. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPEX 2000?

LAPEX 2000 is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Meridian Co., Ltd.. The 510(k) number is K034009.

When did LAPEX 2000 receive FDA 510(k) clearance?

LAPEX 2000 received FDA 510(k) clearance on 2005-01-21, under 510(k) number K034009.

Who is the listed applicant for LAPEX 2000?

The FDA 510(k) record lists Meridian Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPEX 2000?

The FDA product code for LAPEX 2000 is NHN.

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 Meridian 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.

K102375LUCIAK081962LAPEX BCSK023238MCPULSEK020360ABR-2000K010897MERIDIAN-PORTABLEK001347MERIDIAN-II AND MERDIAN-PLUS

View all 7 devices →

Related Devices (Code: NHN)

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.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation

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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