Cardio Revue Center
FDA 510(k) K820820 · Diasonics, Inc.
510(k) numberK820820
Submission
- Device name
- Cardio Revue Center
- Applicant
- Diasonics, Inc.
Mchenry, IL, US - Received
- March 24, 1982
- Decision date
- April 29, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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| K181372 | ArgosDXG · Traditional | Retia Medical, LLC | 12/13/2018SE |
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| K163334 | LiDCOunity v2 Hemodynamic MonitorDXG · Traditional | Lidco, Ltd. | 06/05/2017SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K962662 | Vingmed Sound Color Flow Mapping SystemIYO · Traditional | 01/02/1997SE |
| K924079 | CFM-800 Color Flow Mapping SystemIYO · Traditional | 09/28/1993SE |
| K911435 | CPA/3.5 MHZ ProbeITX · Traditional | 09/11/1992SE |
| K905200 | Saca, 3.5 MHZ ProbeITX · Traditional | 04/02/1992SE |
| K903562 | CW Doppler 2.25 MHZ ProbeITX · Traditional | 03/02/1992SE |
| K903984 | CW DOPPLER/4.5 MHZITX · Traditional | 06/14/1991SE |
| K896637 | Access(Tm), Software Release 4.11PLPH · Traditional | 01/22/1990SE |
| K893518 | Mt/S Software Release 5.0.LNH · Traditional | 10/27/1989SE |
| K894290 | Access TMLNH · Traditional | 09/07/1989SE |
| K893881 | Access TMLNH · Traditional | 06/23/1989SE |
Questions and answers
When was Cardio Revue Center cleared by the FDA?
Cardio Revue Center (K820820) received a 510(k) decision of Substantially Equivalent on April 29, 1982, 36 days after the submission was received.
What is the product code of K820820?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.