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FDA 510(k)

HANDYDOP

K-Number: K030466 · 2003-09-12

ApplicantElcat, GmbH
Decision Date2003-09-12
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HANDYDOP is the device name listed in this FDA 510(k) record. The listed applicant is Elcat, GmbH. It received FDA 510(k) clearance on 2003-09-12 under 510(k) number K030466. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDYDOP?

HANDYDOP is a medical device that received FDA 510(k) clearance on 2003-09-12. The listed applicant is Elcat, GmbH. The 510(k) number is K030466.

When did HANDYDOP receive FDA 510(k) clearance?

HANDYDOP received FDA 510(k) clearance on 2003-09-12, under 510(k) number K030466.

Who is the listed applicant for HANDYDOP?

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

What is the FDA product code for HANDYDOP?

The FDA product code for HANDYDOP is KNG.

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.

Related Devices (Code: KNG)

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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