Abp for Windows
FDA 510(k) K021517 · Rozinn Electronics, Inc.
510(k) numberK021517
Submission
- Device name
- Abp for Windows
- Applicant
- Rozinn Electronics, Inc.
Glendale, NY, US - Received
- May 10, 2002
- Decision date
- July 24, 2002
- 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Florence Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K061780 | Telephone Electrocardiograph Transmitter and Receiver, TTM for Windows +DXH · Traditional | 09/15/2006SE |
| K042463 | Holter PlusDQK · Traditional | 09/22/2004SE |
| K022540 | Cardio ID+(RZ153+)DSH · Traditional | 10/24/2002SE |
| K020213 | Netlink/NetscanDXH · Traditional | 04/05/2002SE |
| K903331 | Rozinn 151DSH · Traditional | 10/22/1990SE |
Questions and answers
When was Abp for Windows cleared by the FDA?
Abp for Windows (K021517) received a 510(k) decision of Substantially Equivalent on July 24, 2002, 75 days after the submission was received.
What is the product code of K021517?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.