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FDA 510(k)

DOPPLEX ULTRASONIC DOPPLER SYSTEM

K-Number: K873989 · 1988-03-02

ApplicantUltramed, Inc.
Decision Date1988-03-02
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOPPLEX ULTRASONIC DOPPLER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ultramed, Inc.. It received FDA 510(k) clearance on 1988-03-02 under 510(k) number K873989. 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 DOPPLEX ULTRASONIC DOPPLER SYSTEM?

DOPPLEX ULTRASONIC DOPPLER SYSTEM is a medical device that received FDA 510(k) clearance on 1988-03-02. The listed applicant is Ultramed, Inc.. The 510(k) number is K873989.

When did DOPPLEX ULTRASONIC DOPPLER SYSTEM receive FDA 510(k) clearance?

DOPPLEX ULTRASONIC DOPPLER SYSTEM received FDA 510(k) clearance on 1988-03-02, under 510(k) number K873989.

Who is the listed applicant for DOPPLEX ULTRASONIC DOPPLER SYSTEM?

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

What is the FDA product code for DOPPLEX ULTRASONIC DOPPLER SYSTEM?

The FDA product code for DOPPLEX ULTRASONIC DOPPLER SYSTEM is JOP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ultramed, 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.

K882015TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEMK861378ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYSTK862021PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEMK850578PHACOEMULSIFICATION TIP

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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