DOPPLEX ULTRASONIC DOPPLER SYSTEM— 510(k) K873989

Name: FDA 510(k) clearance K873989
Creator: U.S. Food and Drug Administration
Published: 1988-03-02

Substantially Equivalent

Ultramed, Inc.

FDA 510(k) clearance K873989 for DOPPLEX ULTRASONIC DOPPLER SYSTEM, Substantially Equivalent on 1988-03-02. Applicant: Ultramed, Inc.. Device class: 2.

Clearance details

Applicant: Ultramed, Inc.
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 1987-09-30
Decision date: 1988-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOP

view all

K242662 — Falcon/Xpress (Falcon/Xpress)2024-12-18
K233976 — VasoGuard (V10, V8, V6, V4, V2)2024-07-19
K153762 — Smartdop XT62016-05-25
K131623 — SMARTDOP XT2014-01-17
K131860 — VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING2013-09-27

More clearances from Ultramed, Inc.

view all

K882015 — TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM1988-09-08
K861378 — ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST1986-07-07
K862021 — PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM1986-06-23
K850578 — PHACOEMULSIFICATION TIP1985-04-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.