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FDA 510(k)

CW DOPPLER/4.5 MHZ

K-Number: K903984 · 1991-06-14

ApplicantDiasonics, Inc.
Decision Date1991-06-14
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CW DOPPLER/4.5 MHZ is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1991-06-14 under 510(k) number K903984. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CW DOPPLER/4.5 MHZ?

CW DOPPLER/4.5 MHZ is a medical device that received FDA 510(k) clearance on 1991-06-14. The listed applicant is Diasonics, Inc.. The 510(k) number is K903984.

When did CW DOPPLER/4.5 MHZ receive FDA 510(k) clearance?

CW DOPPLER/4.5 MHZ received FDA 510(k) clearance on 1991-06-14, under 510(k) number K903984.

Who is the listed applicant for CW DOPPLER/4.5 MHZ?

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

What is the FDA product code for CW DOPPLER/4.5 MHZ?

The FDA product code for CW DOPPLER/4.5 MHZ is ITX.

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Other records listing Diasonics, Inc. 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.

K962662VINGMED SOUND COLOR FLOW MAPPING SYSTEMK924079CFM-800 COLOR FLOW MAPPING SYSTEMK911435CPA/3.5 MHZ PROBEK905200SACA, 3.5 MHZ PROBEK903562CW DOPPLER 2.25 MHZ PROBEK896637ACCESS(TM), SOFTWARE RELEASE 4.11P

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Related Devices (Code: ITX)

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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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