Cleared Traditional

K890624 - TISSUE OXYGEN MONITOR SYSTEM, MODEL II
(FDA 510(k) Clearance)

K890624 · Baxter Healthcare Corp · Anesthesiology

Dec 1989

Decision

318d

Days

Class 2

Risk

K890624 is an FDA 510(k) clearance for the TISSUE OXYGEN MONITOR SYSTEM, MODEL II, a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II — Special Controls, product code CCE), submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 22, 1989, 318 days after receiving the submission on February 7, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1200.

Submission Details

510(k) Number	K890624 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 1989
Decision Date	December 22, 1989
Days to Decision	318 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—

Device Classification

Product Code	CCE — Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.1200