SONO-VU US(TM), MODIFICATION— 510(k) K921738

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K921738 for SONO-VU US(TM), MODIFICATION, Substantially Equivalent on 1992-04-27. 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: 1992-01-29
Decision date: 1992-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, US

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