Endophys Blood Pressure Monitor model BPM-30
FDA 510(k) K231586 · Endophys Technologies, LLC
510(k) numberK231586
Submission
- Device name
- Endophys Blood Pressure Monitor model BPM-30
- Applicant
- Endophys Technologies, LLC
Dallas, TX, US - Received
- May 31, 2023
- Decision date
- November 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
Other 510(k)s with product code DSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160945 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys Holdings, LLC | 09/26/2016SE |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter BoxDSK · Special | Volcano Corporation | 12/03/2015SE |
| K141615 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys, Inc. | 01/07/2015SE |
| K080670 | Modification to Sphygmocor Cardiovascular Management SystemDSK · Special | Atcor Medical | 04/23/2008SE |
| K070795 | Sphygmocor Cardiovascular Management SystemDSK · Traditional | Atcor Medical Pty, Ltd. | 08/31/2007SE |
| K033738 | Monitoring System, Model Argus PB-2200DSK · Traditional | Schiller AG | 08/24/2004SE |
| K021517 | Abp for WindowsDSK · Traditional | Rozinn Electronics, Inc. | 07/24/2002SE |
| K013943 | Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720DSK · Special | Radi Medical Systems AB | 12/18/2001SE |
| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional | Zoll Medical Corp | 07/31/2001SE |
| K003122 | Smartflow, Model Sfip 2000DSK · Traditional | Florence Medical , Ltd. | 05/14/2001SE |
Questions and answers
When was Endophys Blood Pressure Monitor model BPM-30 cleared by the FDA?
Endophys Blood Pressure Monitor model BPM-30 (K231586) received a 510(k) decision of Substantially Equivalent on November 3, 2023, 156 days after the submission was received.
What is the product code of K231586?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.