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FDA 510(k)

DUPLOREACH

K-Number: K014088 · 2002-06-07

ApplicantBaxter Healthcare Corp
Decision Date2002-06-07
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUPLOREACH is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2002-06-07 under 510(k) number K014088. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPLOREACH?

DUPLOREACH is a medical device that received FDA 510(k) clearance on 2002-06-07. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K014088.

When did DUPLOREACH receive FDA 510(k) clearance?

DUPLOREACH received FDA 510(k) clearance on 2002-06-07, under 510(k) number K014088.

Who is the listed applicant for DUPLOREACH?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUPLOREACH?

The FDA product code for DUPLOREACH is FMF.

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Related Devices (Code: FMF)

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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