Cleared Traditional

OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR

K962648 · Ohmeda Medical · Anesthesiology

Jan 1997

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K962648 is an FDA 510(k) clearance for the OHMEDA MODEL 5330 ANESTHETIC AGENT 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 January 17, 1997, 193 days after receiving the submission on July 8, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1500.

Submission Details

510(k) Number	K962648 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 1996
Decision Date	January 17, 1997
Days to Decision	193 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