Takeda Medical Blood Pressure Meter Model TM-2610
FDA 510(k) K874338 · A&D Engineering, Inc.
510(k) numberK874338
Submission
- Device name
- Takeda Medical Blood Pressure Meter Model TM-2610
- Applicant
- A&D Engineering, Inc.
San Jose, CA, US - Received
- October 21, 1987
- Decision date
- February 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30DSK · Traditional | Endophys Technologies, LLC | 11/03/2023SE |
| 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 |
More from Zoll Medical Corp
| 510(k) | Device | Decision |
|---|---|---|
| K082734 | A&D Medical UA-851THW Digital Blood Pressure MonitorDXN · Special | 11/13/2008SE |
| K062027 | A&D Medical UA-789 Digital Blood Pressure MonitorDXN · Special | 01/19/2007SE |
| K061456 | A & D Medical UM-101 Digital Blood Pressure MonitorDXN · Special | 06/21/2006SE |
| K043217 | A&D Medical UA-767PBT Digital Blood Pressure MonitorDXN · Special | 03/03/2005SE |
| K042967 | A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512DXN · Special | 12/03/2004SE |
| K040371 | A & D Medical UA-767BT Digital Blood Pressure MonitorDXN · Special | 05/19/2004SE |
| K040229 | A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328DXN · Special | 03/19/2004SE |
| K032499 | A & D Medical Lifesource UA-704 Digital Blood Pressure MonitorsDXN · Special | 10/30/2003SE |
| K012472 | A & D Medical Lifesource UA-781, UA781PC, & UA-781T Digital Blood Pressure MonitorsDXN · Traditional | 02/15/2002SE |
| K012013 | Lifesource Models UA-787, Ua 787PC, UA-787TDXN · Traditional | 07/13/2001SE |
Questions and answers
When was Takeda Medical Blood Pressure Meter Model TM-2610 cleared by the FDA?
Takeda Medical Blood Pressure Meter Model TM-2610 (K874338) received a 510(k) decision of Substantially Equivalent on February 5, 1988, 107 days after the submission was received.
What is the product code of K874338?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.