FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL EP-2 CLINICAL STIMULATOR
K Number: K933069
·
Decision Oct 21, 1993
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
9
Applicant Total
3
Review Days
121
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Basic Information
- Device Name
- MODEL EP-2 CLINICAL STIMULATOR
- K Number
- K933069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3720
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ep Medical, Inc.
- Date Received
- June 22, 1993
- Decision Date
- October 21, 1993
- Product Code
- DTA
- 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 |
|---|---|---|---|
| DTA | Tester, Pacemaker Electrode Function | FDA class 2 | Cardiovascular |
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