Cleared Traditional

OHMEDA MODEL 5330 ANESTHETIC MONITOR

K931439 · Ohmeda Medical · Anesthesiology

Oct 1993

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K931439 is an FDA 510(k) clearance for the OHMEDA MODEL 5330 ANESTHETIC MONITOR, a Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (Class II — Special Controls, product code CBQ), submitted by Ohmeda Medical (Louisville, US). The FDA issued a Cleared decision on October 19, 1993, 211 days after receiving the submission on March 22, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1500.

Submission Details

510(k) Number	K931439 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 1993
Decision Date	October 19, 1993
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBQ — Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.1500