Cleared Special

MICROGAS 7650 TRANSCUTANEOUS MONITOR

K991644 · Linde Medical Sensors AG · Anesthesiology

May 1999

Decision

Days

Class 2

Risk

About This 510(k) Submission

K991644 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 21, 1999, 8 days after receiving the submission on May 13, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2500.

Submission Details

510(k) Number	K991644 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 1999
Decision Date	May 21, 1999
Days to Decision	8 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