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FDA 510(k)

ERADIC-ALL

K-Number: K981171 · 1998-12-02

ApplicantTheratechnologies, Inc.
Decision Date1998-12-02
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ERADIC-ALL is the device name listed in this FDA 510(k) record. The listed applicant is Theratechnologies, Inc.. It received FDA 510(k) clearance on 1998-12-02 under 510(k) number K981171. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERADIC-ALL?

ERADIC-ALL is a medical device that received FDA 510(k) clearance on 1998-12-02. The listed applicant is Theratechnologies, Inc.. The 510(k) number is K981171.

When did ERADIC-ALL receive FDA 510(k) clearance?

ERADIC-ALL received FDA 510(k) clearance on 1998-12-02, under 510(k) number K981171.

Who is the listed applicant for ERADIC-ALL?

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

What is the FDA product code for ERADIC-ALL?

The FDA product code for ERADIC-ALL is EIA.

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Other records listing Theratechnologies, 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.

K963621STETHOS

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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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