Horizon 2000 Transcutaneous Gas Monitoring
FDA 510(k) K860124 · Mennen Medical, Inc.
510(k) numberK860124
Submission
- Device name
- Horizon 2000 Transcutaneous Gas Monitoring
- Applicant
- Mennen Medical, Inc.
Clarence, NY, US - Received
- January 14, 1986
- Decision date
- May 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K991644 | Microgas 7650 Transcutaneous MonitorKLK · Special | Linde Medical Sensors AG | 05/21/1999SE |
| 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 |
| K860951 | Kontron Cutaneous PO2 Monitor 820KLK · Traditional | Kontron Instruments, Inc. | 04/09/1986SE |
More from Kontron Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141441 | Menntor X7DSI · Traditional | 01/09/2015SE |
| K131789 | Cerebralogik- AeegOMA · Traditional | 12/27/2013SE |
| K123792 | Horizon Xvu (FFR)DQX · Traditional | 08/30/2013SE |
| K093766 | Vitalogik 6000/6500DSI · Special | 05/07/2010SE |
| K091165 | Horizon XvuDQK · Traditional | 08/07/2009SE |
| K083063 | Bis Interface for Vitalogik Patient MonitorsOLW · Traditional | 12/16/2008SE |
| K081484 | Horizon XvuDQK · Special | 06/20/2008SE |
| K073140 | Vitalogik Model 4000/4500DSI · Special | 11/21/2007SE |
| K071899 | Bis Module for Envoy Patient MonitorOLW · Traditional | 10/22/2007SE |
| K071348 | Ems-Xl Cardiac Electrophysiology SystemDQK · Traditional | 09/07/2007SE |
Questions and answers
When was Horizon 2000 Transcutaneous Gas Monitoring cleared by the FDA?
Horizon 2000 Transcutaneous Gas Monitoring (K860124) received a 510(k) decision of Substantially Equivalent on May 9, 1986, 115 days after the submission was received.
What is the product code of K860124?
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.