SEP 90— 510(k) K904103

Substantially Equivalent

Elema-Schonander, Inc.

FDA 510(k) clearance K904103 for SEP 90, Substantially Equivalent on 1990-11-20. Applicant: Elema-Schonander, Inc.. Device class: 2.

Clearance details

Applicant: Elema-Schonander, Inc.
Product code: Code IZP
Device class: Class 2
Regulation: 21 CFR 892.1870
Advisory panel: Radiology
Date received: 1990-09-06
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZP

K934944 — MPQ-421993-12-15
K911888 — PHILIPS ANGIOPRO1991-10-15
K904144 — PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM1990-12-13
K874451 — OMNIPLANE 200 FILM CHANGER SYSTEM1988-02-11
K854251 — THE CSE FILM CHANGER SYSTEM1985-10-28

More clearances from Elema-Schonander, Inc.

K903576 — PUCK 90M1990-09-04
K842903 — SEP PROGRAMMER FOR PUCK U & UD FILMCHANG1984-08-21
K842911 — PUCK U & UD CUTFILM CHANGERS1984-08-21
K840389 — SEP PROGRAMMER SEP-M/SINGLE-PLANE &1984-02-21
K790792 — PULSE GENERATOR MODEL 6371979-10-12

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