Cleared Traditional

SONO-VU US(TM)

K904583 · E-Z-Em, Inc. · Radiology
Jun 1991
Decision
258d
Days
Class 1
Risk

About This 510(k) Submission

K904583 is an FDA 510(k) clearance for the SONO-VU US(TM), a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I — General Controls, product code HIO), submitted by E-Z-Em, Inc. (Worcester, US). The FDA issued a Cleared decision on June 24, 1991, 258 days after receiving the submission on October 9, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 884.1550.

Submission Details

510(k) Number K904583 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1990
Decision Date June 24, 1991
Days to Decision 258 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code HIO — Sampler, Amniotic Fluid (amniocentesis Tray)
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.1550

Similar Devices — HIO Sampler, Amniotic Fluid (amniocentesis Tray)

All 19
G.E. STERILE AMNIOCENTESIS TRAY
K960203 · GE Medical Systems · Mar 1996
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
K955679 · Contour Fabricators of Florida, Inc. · Mar 1996
AMNIOTEST(TM)
K914419 · Pro-Lab, Inc. · Sep 1993
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
K922960 · Cameo, Inc. · Nov 1992
SONO-VU US(TM), MODIFICATION
K921738 · E-Z-Em, Inc. · Apr 1992
MEGA AMNIOCENTESIS KIT
K915863 · Mega Medical, Inc. · Mar 1992