Monitor, Sensomatiii Oxygen
FDA 510(k) K781910 · Biochem International, Inc.
510(k) numberK781910
Submission
- Device name
- Monitor, Sensomatiii Oxygen
- Applicant
- Biochem International, Inc.
Mchenry, IL, US - Received
- November 14, 1978
- Decision date
- December 26, 1978
- 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
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|---|---|---|---|
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| 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 |
| K860124 | Horizon 2000 Transcutaneous Gas MonitoringKLK · Traditional | Mennen Medical, Inc. | 05/09/1986SE |
More from Mennen Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920083 | Biochem Model 3302 NEWOX2 OximeterDQA · Traditional | 04/11/1994SE |
| K932389 | 8100 Anesthetic Agent MonitorCBS · Traditional | 12/03/1993SE |
| K921388 | Biochem 9100 Multigas Monitor Ibp ModuleDSK · Traditional | 05/26/1993SE |
| K920082 | Biochem Model 3301 NEWOX1 OximeterDQA · Traditional | 01/07/1993SE |
| K911351 | Biochem 9100 Multigas Monitor TEMP/FIO1 Mod,NibpDXN · Traditional | 08/22/1991SE |
| K910381 | Biochem Temperature/ FIO2 ModuleCCL · Traditional | 08/22/1991SE |
| K903222 | Biochem 6100 Non-Invasive MonitorDXN · Traditional | 09/04/1990SE |
| K901861 | Biochem 9100 Multigas MonitorCCK · Traditional | 07/27/1990SE |
| K893877 | Biochem 3100 OximeterDQO · Traditional | 12/20/1989SE |
| K892646 | Biochem 8100 Anesthetic Agent MonitorCBQ · Traditional | 08/31/1989SE |
Questions and answers
When was Monitor, Sensomatiii Oxygen cleared by the FDA?
Monitor, Sensomatiii Oxygen (K781910) received a 510(k) decision of Substantially Equivalent on December 26, 1978, 42 days after the submission was received.
What is the product code of K781910?
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.