Cleared Special

MICROGAS 7650 TRANSCUTANEOUS MONITOR

K003943 · Linde Medical Sensors AG · Anesthesiology

May 2001

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K003943 is an FDA 510(k) clearance for the MICROGAS 7650 TRANSCUTANEOUS MONITOR, a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (Class II — Special Controls, product code KLK), submitted by Linde Medical Sensors AG (Basel, CH). The FDA issued a Cleared decision on May 4, 2001, 134 days after receiving the submission on December 21, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2500.

Submission Details

510(k) Number	K003943 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2000
Decision Date	May 04, 2001
Days to Decision	134 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.2500