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FDA 510(k)

IREX 730 MECHANICAL SECTOR SCANNER

K-Number: K842408 · 1984-11-29

ApplicantIrex Corp.
Decision Date1984-11-29
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IREX 730 MECHANICAL SECTOR SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Irex Corp.. It received FDA 510(k) clearance on 1984-11-29 under 510(k) number K842408. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IREX 730 MECHANICAL SECTOR SCANNER?

IREX 730 MECHANICAL SECTOR SCANNER is a medical device that received FDA 510(k) clearance on 1984-11-29. The listed applicant is Irex Corp.. The 510(k) number is K842408.

When did IREX 730 MECHANICAL SECTOR SCANNER receive FDA 510(k) clearance?

IREX 730 MECHANICAL SECTOR SCANNER received FDA 510(k) clearance on 1984-11-29, under 510(k) number K842408.

Who is the listed applicant for IREX 730 MECHANICAL SECTOR SCANNER?

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 730 MECHANICAL SECTOR SCANNER?

The FDA product code for IREX 730 MECHANICAL SECTOR SCANNER is JAF.

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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 880K840139IREX 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: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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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