Oxycare(Tm) Oxygen Controller/Monitor
FDA 510(k) K924679 · Air-Shields Vickers, Inc.
510(k) numberK924679
Submission
- Device name
- Oxycare(Tm) Oxygen Controller/Monitor
- Applicant
- Air-Shields Vickers, Inc.
Hatboro, PA, US - Received
- September 16, 1992
- Decision date
- February 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
|---|---|---|
| K924297 | Dewette 2 Isolette Incubator HumidifierFMZ · Traditional | 03/18/1993SE |
| K912908 | Air-Shields Micro-Lite Phototherapy SystemLBI · Traditional | 12/13/1991SE |
| K912909 | Solair (TM) Infant Incubator Transparent Hood WarmFMZ · Traditional | 11/05/1991SE |
| K912910 | C100 Infant Incubator Shelf/Mount Rail SystemFMZ · Traditional | 10/30/1991SE |
| K904691 | Air-Shields Vickers Telescan Telecom Display SystHFM · Traditional | 02/19/1991SE |
| K903378 | Model C286 Isolette Infant IncubatorFMZ · Traditional | 10/15/1990SE |
| K895782 | Neonatal Incubator (Accessory)FMZ · Traditional | 12/07/1989SE |
| K884086 | C100 QT Variable Height Adjustment IncubatorFMZ · Traditional | 11/14/1988SE |
Questions and answers
When was Oxycare(Tm) Oxygen Controller/Monitor cleared by the FDA?
Oxycare(Tm) Oxygen Controller/Monitor (K924679) received a 510(k) decision of Substantially Equivalent on February 21, 1995, 888 days after the submission was received.
What is the product code of K924679?
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.