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FDA 510(k)

AUTOMARQER

K-Number: K012805 · 2002-03-13

Decision Date2002-03-13
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOMARQER is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne Research. It received FDA 510(k) clearance on 2002-03-13 under 510(k) number K012805. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMARQER?

AUTOMARQER is a medical device that received FDA 510(k) clearance on 2002-03-13. The listed applicant is Hamilton Thorne Research. The 510(k) number is K012805.

When did AUTOMARQER receive FDA 510(k) clearance?

AUTOMARQER received FDA 510(k) clearance on 2002-03-13, under 510(k) number K012805.

Who is the listed applicant for AUTOMARQER?

The FDA 510(k) record lists Hamilton Thorne Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMARQER?

The FDA product code for AUTOMARQER is POV.

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 Hamilton Thorne Research 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: POV)

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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