FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
K Number: K040495
·
Decision Apr 22, 2004
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
3
Review Days
56
Basic Information
- Device Name
- NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405
- K Number
- K040495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Naimco, Inc.
- Date Received
- February 26, 2004
- Decision Date
- April 22, 2004
- 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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