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FDA 510(k)

PATHFINDER

K-Number: K041477 · 2004-12-09

Decision Date2004-12-09
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PATHFINDER is the device name listed in this FDA 510(k) record. The listed applicant is Armstrong Healthcare Limited. It received FDA 510(k) clearance on 2004-12-09 under 510(k) number K041477. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFINDER?

PATHFINDER is a medical device that received FDA 510(k) clearance on 2004-12-09. The listed applicant is Armstrong Healthcare Limited. The 510(k) number is K041477.

When did PATHFINDER receive FDA 510(k) clearance?

PATHFINDER received FDA 510(k) clearance on 2004-12-09, under 510(k) number K041477.

Who is the listed applicant for PATHFINDER?

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

What is the FDA product code for PATHFINDER?

The FDA product code for PATHFINDER is HAW.

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.

Other records listing Armstrong Healthcare Limited 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.

Related Devices (Code: HAW)

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.

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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