Easi ECG Algorithm
FDA 510(k) K033513 · Philips Medical Systems
510(k) numberK033513
Submission
- Device name
- Easi ECG Algorithm
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- November 6, 2003
- Decision date
- January 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRW – Adaptor, Lead Switching, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2350
- Specialty
- Cardiovascular
Other 510(k)s with product code DRW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020456 | Easi 12 Lead AlgorithmDRW · Special | Philips Medical Systems | 07/09/2002SE |
| K930786 | EpcorDRW · Traditional | Siemens Medical Solutions USA, Inc. | 09/26/1994SE |
| K872781 | Easi Lead System Cable AssemblyDRW · Traditional | Totemite Medical Electronics | 12/29/1987SE |
| K861981 | Electrocardiograph Lead Switching AdaptorDRW · Traditional | Vital Signs, Inc. | 08/25/1986SE |
| K851632 | PCX-100 Patient Input LeadwireDRW · Traditional | Eaton Medical Group | 11/08/1985SE |
| K851627 | KBX-20 Outboard Keyboard Access. for G-2000 ElectrDRW · Traditional | Eaton Medical Group | 11/08/1985SE |
| K761210 | Limb Lead Sel. (ECG Lead Switching Ad.)DRW · Traditional | Physio-Control Corp. | 12/21/1976SE |
More from Physio-Control Corp.
| 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 Easi ECG Algorithm cleared by the FDA?
Easi ECG Algorithm (K033513) received a 510(k) decision of Substantially Equivalent on January 15, 2004, 70 days after the submission was received.
What is the product code of K033513?
The FDA product code is DRW – Adaptor, Lead Switching, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2350.