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FDA 510(k)

ER150/M2

K-Number: K021456 · 2002-08-01

ApplicantWorld of Medicine Lemke GmbH
Decision Date2002-08-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ER150/M2 is the device name listed in this FDA 510(k) record. The listed applicant is World of Medicine Lemke GmbH. It received FDA 510(k) clearance on 2002-08-01 under 510(k) number K021456. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ER150/M2?

ER150/M2 is a medical device that received FDA 510(k) clearance on 2002-08-01. The listed applicant is World of Medicine Lemke GmbH. The 510(k) number is K021456.

When did ER150/M2 receive FDA 510(k) clearance?

ER150/M2 received FDA 510(k) clearance on 2002-08-01, under 510(k) number K021456.

Who is the listed applicant for ER150/M2?

The FDA 510(k) record lists World of Medicine Lemke GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ER150/M2?

The FDA product code for ER150/M2 is GCJ.

Other records listing World of Medicine Lemke GmbH 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.

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Related Devices (Code: GCJ)

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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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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