Cleared Traditional

SPACELABS MEDICAL MULTIGAS ANALYZER

K954962 · Spacelabs, Inc. · Anesthesiology
May 1996
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K954962 is an FDA 510(k) clearance for the SPACELABS MEDICAL MULTIGAS ANALYZER, a Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) (Class II — Special Controls, product code CBR), submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on May 31, 1996, 214 days after receiving the submission on October 30, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1700.

Submission Details

510(k) Number K954962 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1995
Decision Date May 31, 1996
Days to Decision 214 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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