Biochem 9100 Multigas Monitor TEMP/FIO1 Mod,Nibp
FDA 510(k) K911351 · Biochem International, Inc.
510(k) numberK911351
Submission
- Device name
- Biochem 9100 Multigas Monitor TEMP/FIO1 Mod,Nibp
- Applicant
- Biochem International, Inc.
Waukesha, WI, US - Received
- March 27, 1991
- Decision date
- August 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
More from 80 Beats Medical GmbH
| 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 |
| 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 |
Questions and answers
When was Biochem 9100 Multigas Monitor TEMP/FIO1 Mod,Nibp cleared by the FDA?
Biochem 9100 Multigas Monitor TEMP/FIO1 Mod,Nibp (K911351) received a 510(k) decision of Substantially Equivalent on August 22, 1991, 148 days after the submission was received.
What is the product code of K911351?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.