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FDA 510(k)

IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM

K-Number: K827370 · 1982-06-28

ApplicantIrex Corp.
Decision Date1982-06-28
Product Code
DecisionSubstantially Equivalent

Device Summary

IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Irex Corp.. It received FDA 510(k) clearance on 1982-06-28 under 510(k) number K827370. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM?

IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1982-06-28. The listed applicant is Irex Corp.. The 510(k) number is K827370.

When did IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM receive FDA 510(k) clearance?

IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM received FDA 510(k) clearance on 1982-06-28, under 510(k) number K827370.

Who is the listed applicant for IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM?

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

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Other records listing Irex Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K844404IREX PS, PORTABLE SCANNER AND 118K843643COLOR DOPPLER 880K842408IREX 730 MECHANICAL SECTOR SCANNERK840139IREX 720 SECTOR SCANNERK813544IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.K811246DOPPLER ULTRASOUND BLOOD FLOWMETER

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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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