FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K Number: K970491
·
Decision May 30, 1997
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
60
Review Days
109
Basic Information
- Device Name
- DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
- K Number
- K970491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Empi
- Date Received
- February 10, 1997
- Decision Date
- May 30, 1997
- Product Code
- EGJ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | FDA class 2 | Physical Medicine |
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