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FDA 510(k)

CONTIUOUS WAVE DOPPLER ULTRASOUND

K-Number: K802670 · 1980-11-26

ApplicantAmerican Edwards Laboratories
Decision Date1980-11-26
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONTIUOUS WAVE DOPPLER ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1980-11-26 under 510(k) number K802670. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTIUOUS WAVE DOPPLER ULTRASOUND?

CONTIUOUS WAVE DOPPLER ULTRASOUND is a medical device that received FDA 510(k) clearance on 1980-11-26. The listed applicant is American Edwards Laboratories. The 510(k) number is K802670.

When did CONTIUOUS WAVE DOPPLER ULTRASOUND receive FDA 510(k) clearance?

CONTIUOUS WAVE DOPPLER ULTRASOUND received FDA 510(k) clearance on 1980-11-26, under 510(k) number K802670.

Who is the listed applicant for CONTIUOUS WAVE DOPPLER ULTRASOUND?

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

What is the FDA product code for CONTIUOUS WAVE DOPPLER ULTRASOUND?

The FDA product code for CONTIUOUS WAVE DOPPLER ULTRASOUND is DXK.

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Related Devices (Code: DXK)

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.

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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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