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FDA 510(k)

DOPPLER ULTRASOUND BLOOD FLOWMETER

K-Number: K811246 · 1981-08-12

ApplicantIrex Corp.
Decision Date1981-08-12
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOPPLER ULTRASOUND BLOOD FLOWMETER is the device name listed in this FDA 510(k) record. The listed applicant is Irex Corp.. It received FDA 510(k) clearance on 1981-08-12 under 510(k) number K811246. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPPLER ULTRASOUND BLOOD FLOWMETER?

DOPPLER ULTRASOUND BLOOD FLOWMETER is a medical device that received FDA 510(k) clearance on 1981-08-12. The listed applicant is Irex Corp.. The 510(k) number is K811246.

When did DOPPLER ULTRASOUND BLOOD FLOWMETER receive FDA 510(k) clearance?

DOPPLER ULTRASOUND BLOOD FLOWMETER received FDA 510(k) clearance on 1981-08-12, under 510(k) number K811246.

Who is the listed applicant for DOPPLER ULTRASOUND BLOOD FLOWMETER?

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 DOPPLER ULTRASOUND BLOOD FLOWMETER?

The FDA product code for DOPPLER ULTRASOUND BLOOD FLOWMETER is DPW.

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Related Devices (Code: DPW)

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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.

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