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FDA 510(k)

COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION

K-Number: K993517 · 1999-11-02

ApplicantMedison America, Inc.
Decision Date1999-11-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 1999-11-02 under 510(k) number K993517. 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 COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION?

COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION is a medical device that received FDA 510(k) clearance on 1999-11-02. The listed applicant is Medison America, Inc.. The 510(k) number is K993517.

When did COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION receive FDA 510(k) clearance?

COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION received FDA 510(k) clearance on 1999-11-02, under 510(k) number K993517.

Who is the listed applicant for COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION?

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

What is the FDA product code for COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION?

The FDA product code for COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION is IYO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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