515A Neo-Trak Neonatal Monitor
FDA 510(k) K861861 · Ge Medical Systems Information Technologies
510(k) numberK861861
Submission
- Device name
- 515A Neo-Trak Neonatal Monitor
- Applicant
- Ge Medical Systems Information Technologies
Wallingford, CT, US - Received
- May 14, 1986
- Decision date
- July 10, 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 |
| 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 |
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Questions and answers
When was 515A Neo-Trak Neonatal Monitor cleared by the FDA?
515A Neo-Trak Neonatal Monitor (K861861) received a 510(k) decision of Substantially Equivalent on July 10, 1986, 57 days after the submission was received.
What is the product code of K861861?
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.