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FDA 510(k)

TRUE VISION, TRUE VISION II

K-Number: K974542 · 1998-02-17

ApplicantMedical Dynamics, Inc.
Decision Date1998-02-17
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRUE VISION, TRUE VISION II is the device name listed in this FDA 510(k) record. The listed applicant is Medical Dynamics, Inc.. It received FDA 510(k) clearance on 1998-02-17 under 510(k) number K974542. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE VISION, TRUE VISION II?

TRUE VISION, TRUE VISION II is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is Medical Dynamics, Inc.. The 510(k) number is K974542.

When did TRUE VISION, TRUE VISION II receive FDA 510(k) clearance?

TRUE VISION, TRUE VISION II received FDA 510(k) clearance on 1998-02-17, under 510(k) number K974542.

Who is the listed applicant for TRUE VISION, TRUE VISION II?

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

What is the FDA product code for TRUE VISION, TRUE VISION II?

The FDA product code for TRUE VISION, TRUE VISION II is EIA.

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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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