FDA 510(k)

IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.

K-Number: K813544 · 1982-02-05

Decision Date1982-02-05

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Irex Corp.. It received FDA 510(k) clearance on 1982-02-05 under 510(k) number K813544. 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 IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.?

IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. is a medical device that received FDA 510(k) clearance on 1982-02-05. The listed applicant is Irex Corp.. The 510(k) number is K813544.

When did IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. receive FDA 510(k) clearance?

IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. received FDA 510(k) clearance on 1982-02-05, under 510(k) number K813544.

Who is the listed applicant for IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.?

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

What is the FDA product code for IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.?

The FDA product code for IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. is IYN.

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Other records listing Irex 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.