Philips ECG Algorithm
FDA 510(k) K073376 · Philips Medical Systems
510(k) numberK073376
Submission
- Device name
- Philips ECG Algorithm
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- December 3, 2007
- Decision date
- April 11, 2008
- 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 |
| K083749 | CARDIOVIEW32 Review ModuleLOS · Special | Qrs Diagnostic, LLC | 03/10/2009SE |
| 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 |
|---|---|---|
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemIYN · Traditional | 09/24/2021SE |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | 09/08/2021SE |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50…DPS · Special | 06/30/2021SE |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph…DPS · Traditional | 09/29/2020SE |
| K192875 | Philips Biosensor BX100DRG · Traditional | 04/16/2020SE |
| K183387 | M3290B Patient Information Center iXMHX · Traditional | 08/06/2019SE |
| K180017 | MX40 Release C.01MHX · Special | 07/24/2018SE |
| K172226 | MX40 Release B.07MHX · Traditional | 11/09/2017SE |
| K163584 | M3290B Philips IntelliVue Information Center iXMHX · Traditional | 07/07/2017SE |
| K163649 | SureSigns VS3; SureSigns VS4DSJ · Special | 03/31/2017SE |
Questions and answers
When was Philips ECG Algorithm cleared by the FDA?
Philips ECG Algorithm (K073376) received a 510(k) decision of Substantially Equivalent on April 11, 2008, 130 days after the submission was received.