Cardioday
FDA 510(k) K130516 · Getemed Medizin- Und Informationstechnik AG
510(k) numberK130516
Submission
- Device name
- Cardioday
- Applicant
- Getemed Medizin- Und Informationstechnik AG
Teltow, Brandenburg, DE - Received
- February 27, 2013
- Decision date
- August 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
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| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K162023 | CardioDay V2.5DQK · Traditional | 03/24/2017SE |
| K130785 | Seer 1000MWJ · Special | 07/26/2013SE |
| K122272 | CardiomemMWJ · Special | 03/28/2013SE |
| K063042 | Cardiomem CM 3000-12BTMWJ · Special | 05/30/2007SE |
| K070280 | Cardioday, Version 2.0DQK · Special | 02/23/2007SE |
| K051686 | Cardiomem CM 3000-12MWJ · Abbreviated | 07/14/2005SE |
| K051471 | CardiodayDQK · Traditional | 06/29/2005SE |
Questions and answers
When was Cardioday cleared by the FDA?
Cardioday (K130516) received a 510(k) decision of Substantially Equivalent on August 23, 2013, 177 days after the submission was received.
What is the product code of K130516?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.