Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512
FDA 510(k) K900246 · Ppg Industries, Inc.
510(k) numberK900246
Submission
- Device name
- Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512
- Applicant
- Ppg Industries, Inc.
Pleasantville, NY, US - Received
- January 17, 1990
- Decision date
- July 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
More from Memtec Corporation
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|---|---|---|
| K922631 | Statpal II Blood Gas Analysis SystemCHL · Traditional | 11/10/1992SE |
| K913358 | Midas System(Tm) 5100 Physiolog Monit/Record SystDXG · Traditional | 12/20/1991SE |
| K914560 | Stat Pal Sensyr Syringe Assembly for Use W/StatpalCHL · Traditional | 11/29/1991SE |
| K912627 | Midas System 2500, Physiological Monitoring SystemMHX · Traditional | 09/10/1991SE |
| K903965 | Statpal Blood Gas Monitoring SystemCHL · Traditional | 12/26/1990SE |
| K901514 | XR Model H Physiological Monitor & Recording Sys.DSK · Traditional | 11/16/1990SE |
| K901132 | Sara SatcapCCK · Traditional | 05/22/1990SE |
| K896442 | PPG Biomedical Ventilator Model IrisaCBK · Traditional | 04/16/1990SE |
| K900700 | Smu 611 UniversalmonitorDPS · Traditional | 04/03/1990SE |
| K890875 | Cardiotest EK53/EK53R, Cardiognost EK56/EK512DPS · Traditional | 10/17/1989SE |
Questions and answers
When was Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512 cleared by the FDA?
Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512 (K900246) received a 510(k) decision of Substantially Equivalent on July 3, 1990, 167 days after the submission was received.
What is the product code of K900246?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.