Monitoring System, Model Argus PB-2200
FDA 510(k) K033738 · Schiller AG
510(k) numberK033738
Submission
- Device name
- Monitoring System, Model Argus PB-2200
- Applicant
- Schiller AG
Baar, CH - Received
- November 28, 2003
- Decision date
- August 24, 2004
- 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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| 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 |
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| K063814 | BP-200 PlusDXN · Traditional | 03/07/2007SE |
| K053207 | Argus, Model LCMMHX · Traditional | 05/19/2006SE |
| K051368 | BR 102 Plus Blood Pressure Holter SystemDXN · Traditional | 08/09/2005SE |
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Questions and answers
When was Monitoring System, Model Argus PB-2200 cleared by the FDA?
Monitoring System, Model Argus PB-2200 (K033738) received a 510(k) decision of Substantially Equivalent on August 24, 2004, 270 days after the submission was received.
What is the product code of K033738?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.