Ep-Workmate with RPM System
FDA 510(k) K032225 · Ep Medsystems
510(k) numberK032225
Submission
- Device name
- Ep-Workmate with RPM System
- Applicant
- Ep Medsystems
West Berlin, NJ, US - Received
- July 21, 2003
- Decision date
- August 20, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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More from iRhythm Technologies, Inc.
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| K092913 | EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04JOQ · Special | 10/16/2009SE |
| K073709 | Modification to Viewmate SystemIYN · Special | 03/11/2008SE |
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| K070706 | Ep-WorkmateDQK · Special | 04/11/2007SE |
| K063277 | MapmateDQK · Special | 11/30/2006SE |
| K063113 | Ep-WorkmateDQK · Special | 10/27/2006SE |
| K041442 | EP-4 Clinical StimutatorJOQ · Special | 09/14/2004SE |
| K033963 | Ep Deflectable CathetersDRF · Special | 04/15/2004SE |
| K040207 | EP-4 Clinical StimulatorJOQ · Special | 02/27/2004SE |
| K031066 | Viewmate Ultrasound Imaging SystemIYN · Traditional | 10/17/2003SE |
Questions and answers
When was Ep-Workmate with RPM System cleared by the FDA?
Ep-Workmate with RPM System (K032225) received a 510(k) decision of Substantially Equivalent on August 20, 2003, 30 days after the submission was received.
What is the product code of K032225?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.