Cleared Special

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES

K053599 · Spacelabs Medical, Inc. · Anesthesiology
Apr 2006
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K053599 is an FDA 510(k) clearance for the SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES, a Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) (Class II — Special Controls, product code CBR), submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on April 19, 2006, 117 days after receiving the submission on December 23, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1700.

Submission Details

510(k) Number K053599 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2005
Decision Date April 19, 2006
Days to Decision 117 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBR — Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1700