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FDA 510(k)

ECONOLITH EM1000

K-Number: K063504 · 2007-03-09

ApplicantMedispec, Ltd.
Decision Date2007-03-09
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ECONOLITH EM1000 is the device name listed in this FDA 510(k) record. The listed applicant is Medispec, Ltd.. It received FDA 510(k) clearance on 2007-03-09 under 510(k) number K063504. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECONOLITH EM1000?

ECONOLITH EM1000 is a medical device that received FDA 510(k) clearance on 2007-03-09. The listed applicant is Medispec, Ltd.. The 510(k) number is K063504.

When did ECONOLITH EM1000 receive FDA 510(k) clearance?

ECONOLITH EM1000 received FDA 510(k) clearance on 2007-03-09, under 510(k) number K063504.

Who is the listed applicant for ECONOLITH EM1000?

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

What is the FDA product code for ECONOLITH EM1000?

The FDA product code for ECONOLITH EM1000 is LNS.

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 Medispec, 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.

K210166Omnispec ED1000K040461ECONOLITH E3000, MODEL 3000 (SW-6)K974796LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER

Related Devices (Code: LNS)

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.

K261086Break WaveSonomotion, Inc.K252913Break WaveSonomotion, Inc.K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.K221903Delta III ProDornier Medtech America, Inc.K213772LM-9300 Plus LithotripterLite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy America

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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