SONO-VU US(TM)— 510(k) K904583

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K904583 for SONO-VU US(TM), Substantially Equivalent on 1991-06-24. Applicant: E-Z-Em, Inc.. Device class: 1.

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1990-10-09
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worcester, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIO

K960203 — G.E. STERILE AMNIOCENTESIS TRAY1996-03-14
K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY1996-03-12
K914419 — AMNIOTEST(TM)1993-09-01
K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE1992-11-05
K921738 — SONO-VU US(TM), MODIFICATION1992-04-27

More clearances from E-Z-Em, Inc.

K071378 — MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES2007-06-13
K062449 — EMPOWERMR INJECTOR SYSTEM, MODEL 97302007-04-13
K063029 — EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/99002006-11-02
K053008 — E-Z-EM ENDOSCOPIC CO2 REGULATOR2005-12-27
K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)2004-07-16

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