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FDA 510(k)

AGATHA-A-H2010

K-Number: K983374 · 1998-12-23

ApplicantMidian Intl.
Decision Date1998-12-23
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AGATHA-A-H2010 is the device name listed in this FDA 510(k) record. The listed applicant is Midian Intl.. It received FDA 510(k) clearance on 1998-12-23 under 510(k) number K983374. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGATHA-A-H2010?

AGATHA-A-H2010 is a medical device that received FDA 510(k) clearance on 1998-12-23. The listed applicant is Midian Intl.. The 510(k) number is K983374.

When did AGATHA-A-H2010 receive FDA 510(k) clearance?

AGATHA-A-H2010 received FDA 510(k) clearance on 1998-12-23, under 510(k) number K983374.

Who is the listed applicant for AGATHA-A-H2010?

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

What is the FDA product code for AGATHA-A-H2010?

The FDA product code for AGATHA-A-H2010 is EFS.

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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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