Cleared Traditional

ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM

K945719 · Sherwood Medical Co. · Anesthesiology

Mar 1995

Decision

115d

Days

Class 1

Risk

About This 510(k) Submission

K945719 is an FDA 510(k) clearance for the ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM, a Arterial Blood Sampling Kit (Class I — General Controls, product code CBT), submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on March 16, 1995, 115 days after receiving the submission on November 21, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1100.

Submission Details

510(k) Number	K945719 FDA.gov
FDA Decision	Cleared SESK
Date Received	November 21, 1994
Decision Date	March 16, 1995
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBT — Arterial Blood Sampling Kit
Device Class	Class I — General Controls
CFR Regulation	21 CFR 868.1100
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.