Biospace
FDA 510(k) K131064 · Biospace Corporation Limited
510(k) numberK131064
Submission
- Device name
- Biospace
- Applicant
- Biospace Corporation Limited
Naples, FL, US - Received
- April 16, 2013
- Decision date
- September 4, 2013
- 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 |
|---|---|---|
| K141483 | Biospace Body Composition AnalyzerMNW · Traditional | 09/23/2014SE |
| K130777 | InbodyMNW · Traditional | 11/25/2013SE |
| K123228 | Inbody 770, Inbody 570, Inbody S10, Inbody H20/INBODY H20(B)MNW · Traditional | 03/08/2013SE |
| K110689 | InbodyMNW · Traditional | 08/19/2011SE |
| K092786 | Inbody, Models: 270, R20, R20BMNW · Traditional | 03/10/2010SE |
| K062603 | Biospace Body Composition Analyzers, Model Inbody 230MNW · Traditional | 02/15/2007SE |
| K052646 | Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20MNW · Special | 12/16/2005SE |
| K042528 | Inbody, Model 3.0MNW · Traditional | 01/11/2005SE |
| K023478 | Inbody AP1 Body Composition AnalyzerMNW · Traditional | 05/13/2003SE |
Questions and answers
When was Biospace cleared by the FDA?
Biospace (K131064) received a 510(k) decision of Substantially Equivalent on September 4, 2013, 141 days after the submission was received.
What is the product code of K131064?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.