DRS-4 DIALYZER REPROCESSING SYSTEM— 510(k) K914580

Name: FDA 510(k) clearance K914580
Creator: U.S. Food and Drug Administration
Published: 1992-02-24

Substantially Equivalent

Seratronics, Inc.

FDA 510(k) clearance K914580 for DRS-4 DIALYZER REPROCESSING SYSTEM, Substantially Equivalent on 1992-02-24. Applicant: Seratronics, Inc.. Device class: 2.

Clearance details

Applicant: Seratronics, Inc.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-16
Decision date: 1992-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIF

view all

K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM2010-11-03
K043126 — ASSIST HEADER CLEANER2005-02-03
K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS2004-11-15
K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM2004-04-27
K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM2003-09-26

More clearances from Seratronics, Inc.

view all

K955299 — DPS 4 DIALYZER PREPARATION SYSTEM1996-10-21
K931336 — DRS 4 DIALYZER REPROCESSING SYSTEM1996-04-18
K944539 — DRS 4 ND DIALYZER REPROCESSING SYSTEM1995-11-29
K923529 — DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES1994-08-29
K874573 — FRESENIUS PURISTERIL 340 (TM)1988-04-25

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