FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EP-WORKMATE WITH RPM SYSTEM
K Number: K032225
·
Decision Aug 20, 2003
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- EP-WORKMATE WITH RPM SYSTEM
- K Number
- K032225
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ep Medsystems
- Date Received
- July 21, 2003
- Decision Date
- August 20, 2003
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Ep Medsystems
| K Number | Device Name | ||
|---|---|---|---|
| K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | Oct 16, 2009 | Substantially Equivalent |
| K073709 | MODIFICATION TO VIEWMATE SYSTEM | Mar 11, 2008 | Substantially Equivalent |
| K071028 | VIEWMATE SYSTEM | May 1, 2007 | Substantially Equivalent |
| K070706 | EP-WORKMATE | Apr 11, 2007 | Substantially Equivalent |
| K063113 | EP-WORKMATE | Oct 27, 2006 | Substantially Equivalent |
| K041442 | EP-4 CLINICAL STIMUTATOR | Sep 14, 2004 | Substantially Equivalent |
| K040207 | EP-4 CLINICAL STIMULATOR | Feb 27, 2004 | Substantially Equivalent |
| K031066 | VIEWMATE ULTRASOUND IMAGING SYSTEM | Oct 17, 2003 | Substantially Equivalent |
| K991001 | MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | Jul 15, 1999 | Substantially Equivalent |
| K984150 | PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | Feb 22, 1999 | Substantially Equivalent |