Siemens SC9000/SC9015 TCP02/C02 Module
FDA 510(k) K980287 · Siemens Medical Solutions USA, Inc.
510(k) numberK980287
Submission
- Device name
- Siemens SC9000/SC9015 TCP02/C02 Module
- Applicant
- Siemens Medical Solutions USA, Inc.
Danvers, MA, US - Received
- January 26, 1998
- Decision date
- August 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Siemens SC9000/SC9015 TCP02/C02 Module cleared by the FDA?
Siemens SC9000/SC9015 TCP02/C02 Module (K980287) received a 510(k) decision of Substantially Equivalent on August 12, 1998, 198 days after the submission was received.
What is the product code of K980287?
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.