Ambulatory Blood Pressure Monitor, Mdl# 5100-01
FDA 510(k) K925899 · Welch Allyn, Inc.
510(k) numberK925899
Submission
- Device name
- Ambulatory Blood Pressure Monitor, Mdl# 5100-01
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- November 20, 1992
- Decision date
- May 21, 1993
- 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
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| 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 |
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Questions and answers
When was Ambulatory Blood Pressure Monitor, Mdl# 5100-01 cleared by the FDA?
Ambulatory Blood Pressure Monitor, Mdl# 5100-01 (K925899) received a 510(k) decision of Substantially Equivalent on May 21, 1993, 182 days after the submission was received.
What is the product code of K925899?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.