DIALYSIS MACHINES DM-346 & 346-1— 510(k) K772163

Name: FDA 510(k) clearance K772163
Creator: U.S. Food and Drug Administration
Published: 1977-11-28

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K772163 for DIALYSIS MACHINES DM-346 & 346-1, Substantially Equivalent on 1977-11-28. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code FIJ
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1977-11-16
Decision date: 1977-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

More clearances from Extracorporeal Medical Specialities, Inc.

view all

K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR1984-11-29
K840262 — HANCOCK PERICARDIAL PATCH1984-05-30
K840532 — HEMOPERFUSION SYSTEM TP-4001984-05-30
K840057 — EXP* 500 PARALLEL PLATE DIALYZER1984-02-04
K840146 — EXP* 700 PARALLEL PLATE DIALYZER1984-02-04

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