Cleared Traditional

NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY

K895149 · Shiley, Inc. · Anesthesiology

Nov 1989

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K895149 is an FDA 510(k) clearance for the NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY, a Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (Class II — Special Controls, product code CCE), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on November 28, 1989, 97 days after receiving the submission on August 23, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1200.

Submission Details

510(k) Number	K895149 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 1989
Decision Date	November 28, 1989
Days to Decision	97 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