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FDA 510(k)

IREX PS, PORTABLE SCANNER AND 118

K-Number: K844404 · 1985-02-04

ApplicantIrex Corp.
Decision Date1985-02-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IREX PS, PORTABLE SCANNER AND 118 is the device name listed in this FDA 510(k) record. The listed applicant is Irex Corp.. It received FDA 510(k) clearance on 1985-02-04 under 510(k) number K844404. 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 IREX PS, PORTABLE SCANNER AND 118?

IREX PS, PORTABLE SCANNER AND 118 is a medical device that received FDA 510(k) clearance on 1985-02-04. The listed applicant is Irex Corp.. The 510(k) number is K844404.

When did IREX PS, PORTABLE SCANNER AND 118 receive FDA 510(k) clearance?

IREX PS, PORTABLE SCANNER AND 118 received FDA 510(k) clearance on 1985-02-04, under 510(k) number K844404.

Who is the listed applicant for IREX PS, PORTABLE SCANNER AND 118?

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 PS, PORTABLE SCANNER AND 118?

The FDA product code for IREX PS, PORTABLE SCANNER AND 118 is IYO.

Related Clinical Trials

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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.

K843643COLOR DOPPLER 880K842408IREX 730 MECHANICAL SECTOR SCANNERK840139IREX 720 SECTOR SCANNERK827370IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEMK813544IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.K811246DOPPLER ULTRASOUND BLOOD FLOWMETER

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Related Devices (Code: IYO)

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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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