Microgas 7650 Transcutaneous Monitor

Q: What is the product code of K991644?

The FDA product code is KLK – Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.2500.

FDA 510(k) K991644 · Linde Medical Sensors AG

Substantially Equivalent

510(k) numberK991644

Submission

Device name: Microgas 7650 Transcutaneous Monitor
Applicant: Linde Medical Sensors AG
Basel, CH
Received: May 13, 1999
Decision date: May 21, 1999
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KLK – Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.2500
Specialty: Anesthesiology

Other 510(k)s with product code KLK

510(k)	Device	Applicant	Decision
K003943	Microgas 7650 Transcutaneous MonitorKLK · Special	Linde Medical Sensors AG	05/04/2001SE
K980287	Siemens SC9000/SC9015 TCP02/C02 ModuleKLK · Traditional	Siemens Medical Solutions USA, Inc.	08/12/1998SE
K924709	Satcare Oxygen Controller/Monitor W/ Pulse OximeteKLK · Traditional	Air-Shields, Inc.	01/17/1996SE
K924679	Oxycare(Tm) Oxygen Controller/MonitorKLK · Traditional	Air-Shields Vickers, Inc.	02/21/1995SE
K925910	Hewlett-Packard Model M1018A TCPO2/TOPCO2 ModuleKLK · Traditional	Hewlett-Packard Co.	07/29/1993SE
K893133	Horizon 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXXKLK · Traditional	Mennen Medical, Inc.	07/14/1989SE
K870805	Model 840 Transcutan. Oxygen/Carbon Diox. MonitorKLK · Traditional	Novametrix Medical Systems, Inc.	05/27/1987SE
K861861	515A Neo-Trak Neonatal MonitorKLK · Traditional	Ge Medical Systems Information Technologies	07/10/1986SE
K860124	Horizon 2000 Transcutaneous Gas MonitoringKLK · Traditional	Mennen Medical, Inc.	05/09/1986SE
K860951	Kontron Cutaneous PO2 Monitor 820KLK · Traditional	Kontron Instruments, Inc.	04/09/1986SE

More from Kontron Instruments, Inc.

510(k)	Device	Decision
K043357	Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009LKD · Traditional	03/04/2005SE
K032291	Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemDOA · Traditional	08/24/2004SE
K003943	Microgas 7650 Transcutaneous MonitorKLK · Special	05/04/2001SE

Questions and answers

When was Microgas 7650 Transcutaneous Monitor cleared by the FDA?

Microgas 7650 Transcutaneous Monitor (K991644) received a 510(k) decision of Substantially Equivalent on May 21, 1999, 8 days after the submission was received.

What is the product code of K991644?

The FDA product code is KLK – Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.2500.