Epicardia Pc/Fc
FDA 510(k) K883103 · Medicomp, Inc.
510(k) numberK883103
Submission
- Device name
- Epicardia Pc/Fc
- Applicant
- Medicomp, Inc.
West Melbourne, FL, US - Received
- July 22, 1988
- Decision date
- September 22, 1988
- 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
Other 510(k)s with product code DSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K173170 | Epicardia AnywhereDSI · Special | 01/10/2018SE |
| K161916 | TelePatch Cardiac MonitorDRG · Traditional | 12/21/2016SE |
| K091696 | Savi Wireless, Model PM500DRG · Special | 10/26/2009SE |
| K090834 | Epicardia 5000DSI · Special | 05/15/2009SE |
| K043454 | Cardiopal Ai with Diogenes SV (Cardiopal SV), Model PM410MLO · Special | 03/24/2005SE |
| K981119 | Cardiopal Model Number PM20DXH · Traditional | 10/14/1998SE |
| K952846 | EpicardiaDQK · Traditional | 09/18/1995SE |
| K943915 | Heat and Moisture Exchanger Filter (Hme)BYD · Traditional | 10/14/1994SE |
| K900207 | Epicardia 4000DST · Traditional | 07/31/1990SE |
| K881770 | Epicardia Le/FdDQK · Traditional | 05/31/1988SE |
Questions and answers
When was Epicardia Pc/Fc cleared by the FDA?
Epicardia Pc/Fc (K883103) received a 510(k) decision of Substantially Equivalent on September 22, 1988, 62 days after the submission was received.
What is the product code of K883103?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.