SPEACELABS MULTIGAS MODULE— 510(k) K112173

Name: FDA 510(k) clearance K112173
Creator: U.S. Food and Drug Administration
Published: 2011-10-05

Substantially Equivalent

Spacelabs Healthcare

FDA 510(k) clearance K112173 for SPEACELABS MULTIGAS MODULE, Substantially Equivalent on 2011-10-05. Applicant: Spacelabs Healthcare. Device class: 2.

Clearance details

Applicant: Spacelabs Healthcare
Product code: Code CBR
Device class: Class 2
Regulation: 21 CFR 868.1700
Advisory panel: Anesthesiology
Date received: 2011-07-28
Decision date: 2011-10-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Nederland, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBR

view all

K053599 — SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES2006-04-19
K954962 — SPACELABS MEDICAL MULTIGAS ANALYZER1996-05-31
K904843 — OSCAR(TM) II CAPNOMETER & PULSE OXIMETER1991-04-09
K853360 — N20 TEST1985-09-03

More clearances from Spacelabs Healthcare

view all

K150329 — elance Vital Signs Monitor, Central Monitor Software2015-11-05
K141156 — SPACELABS HEALTHCARE TELEMETRY RECEIVER2014-09-09
K122146 — XHIBIT CENTRAL STATION, MODEL 961022013-04-22
K130112 — CAPNO MODULE, 925172013-03-21
K121017 — CAPNOGRAPHY PAD (92516)2012-07-13

Recalls naming K112173

K-number listed on FDA's recall record

Z-2077-2014 — Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.Class II·Terminated·Spacelabs Healthcare Inc·20140618

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112173.

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