Biochem Temperature/ FIO2 Module
FDA 510(k) K910381 · Biochem International, Inc.
510(k) numberK910381
Submission
- Device name
- Biochem Temperature/ FIO2 Module
- Applicant
- Biochem International, Inc.
Waukesha, WI, US - Received
- January 29, 1991
- Decision date
- August 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1720
- Specialty
- Anesthesiology
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| K213948 | OxyMinderCCL · Traditional | Bio-Med Devices, Inc. | 03/17/2022SE |
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| K153659 | MaxO2MECCL · Traditional | Maxtec, LLC | 06/10/2016SE |
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| K911351 | Biochem 9100 Multigas Monitor TEMP/FIO1 Mod,NibpDXN · 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 |
Questions and answers
When was Biochem Temperature/ FIO2 Module cleared by the FDA?
Biochem Temperature/ FIO2 Module (K910381) received a 510(k) decision of Substantially Equivalent on August 22, 1991, 205 days after the submission was received.
What is the product code of K910381?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.