Cardioview 3000 Software
FDA 510(k) K974352 · Micromedical, Inc.
510(k) numberK974352
Submission
- Device name
- Cardioview 3000 Software
- Applicant
- Micromedical, Inc.
Northbrook, IL, US - Received
- November 19, 1997
- Decision date
- September 8, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K083749 | CARDIOVIEW32 Review ModuleLOS · Special | Qrs Diagnostic, LLC | 03/10/2009SE |
| 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 |
More from Nihon Kohden America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974220 | Micromedical 12 Lead Simultaneous CableDPS · Traditional | 08/25/1998SE |
| K974351 | Biolog 3000 ElectrocardiographDPS · Traditional | 04/01/1998SE |
| K970305 | Printer InterfaceDXH · Traditional | 08/15/1997SE |
| K955891 | Cardioview Transtelephonic SoftwareDPS · Traditional | 10/08/1996SE |
| K895535 | PaceviewKRE · Traditional | 03/19/1990SE |
| K895534 | BiologDRT · Traditional | 03/19/1990SE |
Questions and answers
When was Cardioview 3000 Software cleared by the FDA?
Cardioview 3000 Software (K974352) received a 510(k) decision of Substantially Equivalent on September 8, 1998, 293 days after the submission was received.