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FDA 510(k)

ECHOFLOW DOPPLER BLOOD VELOCITY METER

K-Number: K990642 · 1999-09-16

ApplicantEchocath, Inc.
Decision Date1999-09-16
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHOFLOW DOPPLER BLOOD VELOCITY METER is the device name listed in this FDA 510(k) record. The listed applicant is Echocath, Inc.. It received FDA 510(k) clearance on 1999-09-16 under 510(k) number K990642. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOFLOW DOPPLER BLOOD VELOCITY METER?

ECHOFLOW DOPPLER BLOOD VELOCITY METER is a medical device that received FDA 510(k) clearance on 1999-09-16. The listed applicant is Echocath, Inc.. The 510(k) number is K990642.

When did ECHOFLOW DOPPLER BLOOD VELOCITY METER receive FDA 510(k) clearance?

ECHOFLOW DOPPLER BLOOD VELOCITY METER received FDA 510(k) clearance on 1999-09-16, under 510(k) number K990642.

Who is the listed applicant for ECHOFLOW DOPPLER BLOOD VELOCITY METER?

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

What is the FDA product code for ECHOFLOW DOPPLER BLOOD VELOCITY METER?

The FDA product code for ECHOFLOW DOPPLER BLOOD VELOCITY METER is JOP.

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Other records listing Echocath, 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.

K010482ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1K932436ECHOMARK INTRAUTERINE GUIDING CATHETERK933417ECHOMARK(R) ELECTROPHYSIOLOGY CATHETERK926351COLORMARK(TM) VISUALIZATION SYSTEMK922787ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION

Related Devices (Code: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

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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