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FDA 510(k)

TRISCAN, MODELS 38,40,41,43 & 45

K-Number: K811316 · 1981-07-02

ApplicantVisidyne Corp.
Decision Date1981-07-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRISCAN, MODELS 38,40,41,43 & 45 is the device name listed in this FDA 510(k) record. The listed applicant is Visidyne Corp.. It received FDA 510(k) clearance on 1981-07-02 under 510(k) number K811316. 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 TRISCAN, MODELS 38,40,41,43 & 45?

TRISCAN, MODELS 38,40,41,43 & 45 is a medical device that received FDA 510(k) clearance on 1981-07-02. The listed applicant is Visidyne Corp.. The 510(k) number is K811316.

When did TRISCAN, MODELS 38,40,41,43 & 45 receive FDA 510(k) clearance?

TRISCAN, MODELS 38,40,41,43 & 45 received FDA 510(k) clearance on 1981-07-02, under 510(k) number K811316.

Who is the listed applicant for TRISCAN, MODELS 38,40,41,43 & 45?

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

What is the FDA product code for TRISCAN, MODELS 38,40,41,43 & 45?

The FDA product code for TRISCAN, MODELS 38,40,41,43 & 45 is IYO.

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Other records listing Visidyne Corp. as applicant

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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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