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FDA 510(k)

ERCHONIA PL2000

K-Number: K012580 · 2002-01-17

ApplicantTuco Innovations, Inc.
Decision Date2002-01-17
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ERCHONIA PL2000 is the device name listed in this FDA 510(k) record. The listed applicant is Tuco Innovations, Inc.. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K012580. 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 ERCHONIA PL2000?

ERCHONIA PL2000 is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Tuco Innovations, Inc.. The 510(k) number is K012580.

When did ERCHONIA PL2000 receive FDA 510(k) clearance?

ERCHONIA PL2000 received FDA 510(k) clearance on 2002-01-17, under 510(k) number K012580.

Who is the listed applicant for ERCHONIA PL2000?

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

What is the FDA product code for ERCHONIA PL2000?

The FDA product code for ERCHONIA PL2000 is NHN.

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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.

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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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