GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM— 510(k) K120532

Name: FDA 510(k) clearance K120532
Creator: U.S. Food and Drug Administration
Published: 2013-05-02

Substantially Equivalent

Getinge Sourcing, LLC

FDA 510(k) clearance K120532 for GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM, Substantially Equivalent on 2013-05-02. Applicant: Getinge Sourcing, LLC. Device class: 2.

Clearance details

Applicant: Getinge Sourcing, LLC
Product code: Code PEC
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2012-02-22
Decision date: 2013-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

More clearances from Getinge Sourcing, LLC

view all

K153713 — Getinge Series Warming Cabinet2016-06-07
K122625 — GETINGE 800HC- SERIES STEAM STERILIZER2013-05-22
K122071 — GETINGE 400HC-E / SERIES STEAM STERILIZER2013-03-12
K120441 — GETINGE 700HC-E SERIES STEAM STERILIZER2012-05-31
K103504 — GETINGE 400HC/500HC SERIES STEAM STERILIZER2011-03-16

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