510(k) K991644

MICROGAS 7650 TRANSCUTANEOUS MONITOR by Linde Medical Sensors AG — Product Code KLK

K991644 is an FDA 510(k) premarket notification submitted by Linde Medical Sensors AG for the device "MICROGAS 7650 TRANSCUTANEOUS MONITOR". The FDA issued a decision of Substantially Equivalent on May 21, 1999. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Linde Medical Sensors AG has at least 3 other 510(k) clearances on record.