BP800, 850 1000
FDA 510(k) K841095 · Associated Mills, Inc.
510(k) numberK841095
Submission
- Device name
- BP800, 850 1000
- Applicant
- Associated Mills, Inc.
Mchenry, IL, US - Received
- March 13, 1984
- Decision date
- August 24, 1984
- 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 |
|---|---|---|
| K901459 | DS60 Toothbrush SanitizerMCF · Traditional | 09/17/1990SE |
| K872327 | Whirlpool Aerator WB700, WB800, WB900, WB975ILJ · Traditional | 09/04/1987SE |
| K871661 | WH150 Room HumidifierKFZ · Traditional | 06/15/1987SE |
| K862041 | WM10, WM20, WM30 Power MassagerISA · Traditional | 06/17/1986SE |
| K862042 | SH20, SH30 & SH50 Ultrasonic HumidifierKFZ · Traditional | 06/05/1986SE |
| K844397 | Pollenex Digital Sphygmomanometer BP-4000DSK · Traditional | 04/18/1985SE |
| K844396 | Pollenex Digital Sphygmomanometer BP-2000DSK · Traditional | 04/18/1985SE |
| K850363 | Pollenex Digital Thermometer T-225FLL · Traditional | 02/15/1985SE |
| K850362 | Pollenex Digital Thermometer T-125FLL · Traditional | 02/15/1985SE |
| K841100 | HP-20, 30, 40, 50 & 60IRT · Traditional | 03/23/1984SE |
Questions and answers
When was BP800, 850 1000 cleared by the FDA?
BP800, 850 1000 (K841095) received a 510(k) decision of Substantially Equivalent on August 24, 1984, 164 days after the submission was received.
What is the product code of K841095?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.