FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇨🇦 Canada
ISOTRON III, ISOTRON IV
K Number: K955387
·
Decision Mar 22, 1996
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
72
Applicant Total
58
Review Days
121
Basic Information
- Device Name
- ISOTRON III, ISOTRON IV
- K Number
- K955387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- EXCEL TECH. LTD.
- Date Received
- November 22, 1995
- Decision Date
- March 22, 1996
- Product Code
- LIH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LIH | Interferential Current Therapy | FDA class 2 | Neurology |
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