6004 Nibp Monitor with Temperature
FDA 510(k) K983796 · Bci Intl., Inc.
510(k) numberK983796
Submission
- Device name
- 6004 Nibp Monitor with Temperature
- Applicant
- Bci Intl., Inc.
Waukesha, WI, US - Received
- October 27, 1998
- Decision date
- January 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K991410 | 3402 Handheld Pulse OximeterDQA · Traditional | 06/09/1999SE |
| K991086 | Capnocheck II, Model 8400CCK · Traditional | 06/09/1999SE |
| K984618 | Bci Mini-Torr Plus, Model 6004DXN · Traditional | 03/25/1999SE |
| K982279 | Vital Signs Monitor; Advisor Model # Bci 9200MHX · Traditional | 09/25/1998SE |
| K981939 | Autocorr Plus; 3404 Oximeter/Ecg MonitorDQA · Traditional | 08/20/1998SE |
| K980714 | Bci 3401 Handheld Pulse OximeterDQA · Traditional | 03/25/1998SE |
| K974697 | Reusable Finger Sensor 3444DQH · Traditional | 03/11/1998SE |
| K970801 | Bci Model 6004 Nibp Monitor (6004)DXN · Traditional | 11/12/1997SE |
| K970209 | Capnocheck PlusCCK · Traditional | 04/18/1997SE |
| K963496 | Oxi TempDQA · Traditional | 11/26/1996SE |
Questions and answers
When was 6004 Nibp Monitor with Temperature cleared by the FDA?
6004 Nibp Monitor with Temperature (K983796) received a 510(k) decision of Substantially Equivalent on January 22, 1999, 87 days after the submission was received.
What is the product code of K983796?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.