FDA 510(k)

BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3

K-Number: K012369 · 2001-08-10

Decision Date2001-08-10

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 is the device name listed in this FDA 510(k) record. The listed applicant is Atys Medical. It received FDA 510(k) clearance on 2001-08-10 under 510(k) number K012369. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3?

BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 is a medical device that received FDA 510(k) clearance on 2001-08-10. The listed applicant is Atys Medical. The 510(k) number is K012369.

When did BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 receive FDA 510(k) clearance?

BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 received FDA 510(k) clearance on 2001-08-10, under 510(k) number K012369.

Who is the listed applicant for BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3?

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

What is the FDA product code for BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3?

The FDA product code for BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 is IYN.

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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.