MAMEX DC AMI SL12/MG15— 510(k) K905748

Substantially Equivalent

Soredex, Inc.

FDA 510(k) clearance K905748 for MAMEX DC AMI SL12/MG15, Substantially Equivalent on 1991-03-07. Applicant: Soredex, Inc.. Device class: 2.

Clearance details

Applicant: Soredex, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1990-12-26
Decision date: 1991-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sf-00511 Helsinki Finland, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZH

K203509 — SMART FINDER2021-07-14
K202294 — Affirm Contrast Biopsy2020-10-05
K191495 — Biopsy Positioner2019-07-03
K161575 — Affirm Lateral Arm Upright Biopsy Accessory2016-08-10
K161920 — Comfort Cover2016-07-15

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