FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K Number: K894549
·
Decision Feb 9, 1990
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
72
Applicant Total
44
Review Days
204
Basic Information
- Device Name
- DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
- K Number
- K894549
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5525
- Medical Specialty
- Physical Medicine
- Decision
- Unknown
- Applicant
- Henley Intl.
- Date Received
- July 20, 1989
- Decision Date
- February 9, 1990
- 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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