Cardioserver
FDA 510(k) K052883 · Datrix
510(k) numberK052883
Submission
- Device name
- Cardioserver
- Applicant
- Datrix
Escondido, CA, US - Received
- October 13, 2005
- Decision date
- November 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K053083 | Datrix Cardio Wifi ElectrocardiographDPS · Traditional | 11/30/2005SE |
| K031074 | Digital Ambulatory ECG (Holter) RecorderMWJ · Traditional | 10/15/2003SE |
| K982975 | Digital ECG Holter Recorder, Model DR512MWJ · Traditional | 11/10/1998SE |
| K921068 | Gikter ECG Cassette Tape Recorder Model XR 300DSH · Traditional | 03/30/1992SE |
Questions and answers
When was Cardioserver cleared by the FDA?
Cardioserver (K052883) received a 510(k) decision of Substantially Equivalent on November 1, 2005, 19 days after the submission was received.
What is the product code of K052883?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.