CARDIOVIEW32 Review Module
FDA 510(k) K083749 · Qrs Diagnostic, LLC
510(k) numberK083749
Submission
- Device name
- CARDIOVIEW32 Review Module
- Applicant
- Qrs Diagnostic, LLC
Plymouth, MN, US - Received
- December 17, 2008
- Decision date
- March 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
Other 510(k)s with product code LOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090895 | Ekg-Plus II SoftwareLOS · Traditional | Bionet Co., Ltd. | 08/26/2009SE |
| K073376 | Philips ECG AlgorithmLOS · Special | Philips Medical Systems | 04/11/2008SE |
| K023034 | CARDIOTOUCH-3000LOS · Special | Bionet Company, Ltd. | 11/14/2002SE |
| K011328 | Cardio Care EKG-2000 12-CHANNEL ElectrocardiographLOS · Traditional | Bionet Company, Ltd. | 11/21/2001SE |
| K993616 | Cardio-Card Interpretation System ILOS · Traditional | Nasiff Assoc., Inc. | 04/10/2000SE |
| K984465 | Oxyconalpha with Option ECGLOS · Traditional | Erich Jaeger B.V. | 10/27/1999SE |
| K991014 | Case 8000 Exercise Testing SystemLOS · Traditional | General Electric Medical Systems Information Techn | 10/20/1999SE |
| K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac Vu, Mac 8…LOS · Traditional | General Electric Medical Systems Information Techn | 08/19/1999SE |
| K990031 | Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and AccessoriesLOS · Traditional | Nihon Kohden America, Inc. | 04/16/1999SE |
| K984504 | Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q and AccessoriesLOS · Traditional | Nihon Kohden America, Inc. | 04/15/1999SE |
More from Nihon Kohden America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K073630 | Modification to: Bpcard, Model Z-7000-0700DXN · Special | 01/11/2008SE |
| K031964 | BpcardDXN · Traditional | 09/05/2003SE |
| K030535 | Ekgcard SystemDPS · Traditional | 06/11/2003SE |
| K001278 | Sensaire Diagnostic SpirometerBZG · Traditional | 11/29/2000SE |
| K001995 | Spiroxcard Diagnostic Spirometer and Pulse OximeterDQA · Special | 09/08/2000SE |
| K973138 | SpirocardBZG · Traditional | 10/28/1998SE |
Questions and answers
When was CARDIOVIEW32 Review Module cleared by the FDA?
CARDIOVIEW32 Review Module (K083749) received a 510(k) decision of Substantially Equivalent on March 10, 2009, 83 days after the submission was received.