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FDA 510(k)

ECHOTECH 3D FREESCAN

K-Number: K980308 · 1998-05-06

ApplicantEchotech 3D Imaging Systems GmbH
Decision Date1998-05-06
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHOTECH 3D FREESCAN is the device name listed in this FDA 510(k) record. The listed applicant is Echotech 3D Imaging Systems GmbH. It received FDA 510(k) clearance on 1998-05-06 under 510(k) number K980308. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOTECH 3D FREESCAN?

ECHOTECH 3D FREESCAN is a medical device that received FDA 510(k) clearance on 1998-05-06. The listed applicant is Echotech 3D Imaging Systems GmbH. The 510(k) number is K980308.

When did ECHOTECH 3D FREESCAN receive FDA 510(k) clearance?

ECHOTECH 3D FREESCAN received FDA 510(k) clearance on 1998-05-06, under 510(k) number K980308.

Who is the listed applicant for ECHOTECH 3D FREESCAN?

The FDA 510(k) record lists Echotech 3D Imaging Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHOTECH 3D FREESCAN?

The FDA product code for ECHOTECH 3D FREESCAN is IYO.

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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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