Synetec
FDA 510(k) K002817 · Ela Medical, Inc.
510(k) numberK002817
Submission
- Device name
- Synetec
- Applicant
- Ela Medical, Inc.
Plymouth, MN, US - Received
- September 11, 2000
- Decision date
- May 2, 2001
- 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
Other 510(k)s with product code DQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| 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 |
|---|---|---|
| K042002 | Synescope, Easyscope, Synecom, HolterreaderDQK · Traditional | 10/20/2004SE |
| K032466 | SpiderviewMWJ · Special | 08/22/2003SE |
| K993448 | Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…DTB · Traditional | 04/10/2000ST |
| K000029 | Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…DTB · Traditional | 04/04/2000SE |
| K990727 | Syneflash & SyneviewDQK · Traditional | 11/26/1999SE |
| K972574 | Stela Model UJ45 Pacing LeadsDTB · Traditional | 01/08/1998ST |
| K970072 | Opus S Model 4121 and 4124 PacemakersDXY · Traditional | 08/29/1997ST |
| K963738 | Stela Model BJ44 and BJ45 Pacing LeadsDTB · Traditional | 05/23/1997PT |
| K952364 | Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional | 09/01/1995ST |
| K952363 | Opus Pacemakers (Models 4021, 4033, and 4034)ELA · Traditional | 08/15/1995SE |
Questions and answers
When was Synetec cleared by the FDA?
Synetec (K002817) received a 510(k) decision of Substantially Equivalent on May 2, 2001, 233 days after the submission was received.
What is the product code of K002817?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.