Biochem International, Inc.
Medical device manufacturer in Waukesha, WI.
28510(k) clearances
0PMA approvals
0recalls
Device types
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 6
- DQA Oximeter 4
- KLK Monitor, Oxygen, Cutaneous, For Infant Not… 3
- DXN System, Measurement, Blood-Pressure… 3
- CBZ Analyzer, Ion, Hydrogen-Ion (Ph)… 2
- CCC Analyzer, Gas, Carbon-Dioxide, Partial… 1
- KGZ Accessories, Catheter 1
- CBF Chamber, Hyperbaric 1
- BZQ Monitor, Breathing Frequency 1
- CBQ Analyzer, Gas, Enflurane, Gaseous-Phase… 1
- DQO Catheter, Intravascular, Diagnostic 1
- CCL Analyzer, Gas, Oxygen, Gaseous-Phase 1
- DSK Computer, Blood-Pressure 1
- CBS Analyzer, Gas, Halothane, Gaseous-Phase… 1
510(k) clearances
| 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 |
| K890874 | Biochem 520 Breath IndicatorCCK · Traditional | 06/15/1989SE |
| K873856 | Biochem 9090 CAPNOGRAPH/SAO2CCK · Traditional | 12/17/1987SE |
| K873959 | Biochem 8800 CapnometerCCK · Traditional | 12/11/1987SE |
| K871133 | Biochem 8090 CapnographCCK · Traditional | 04/21/1987SE |
| K870163 | Biochem Microspan 1040 OximeterDQA · Traditional | 03/03/1987SE |
| K863186 | Biochem Co/Ox 1000DQA · Traditional | 11/07/1986SE |
| K854333 | Biochem 515 Respiration MonitorBZQ · Traditional | 05/30/1986SE |
| K842303 | Microspan -Ph MonitorCBF · Traditional | 10/12/1984SE |
| K840918 | Micro Span Transcutaneous Oxygen MonitKLK · Traditional | 04/17/1984SE |
| K812643 | Lifespan CO2CCK · Traditional | 11/16/1981SE |
| K811470 | Lifespan 100KLK · Traditional | 06/12/1981SE |
| K803260 | Sensomat Muscle/Tissue PHCBZ · Traditional | 02/02/1981SE |
| K803014 | SensomatCBZ · Traditional | 12/22/1980SE |
| K801657 | Non-Invasive, Blood Pressure MonitorDXN · Traditional | 08/20/1980SE |
| K800073 | Transcutaneous Oxygen Monitor · Traditional | 02/05/1980SE |
| K790597 | Sensomat Sidearm AdapterKGZ · Traditional | 07/10/1979SE |
| K781910 | Monitor, Sensomatiii OxygenKLK · Traditional | 12/26/1978SE |
| K771722 | SensomatCCC · Traditional | 09/26/1977SE |