FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
DYNATRON 850
K Number: K941461
·
Decision Sep 1, 1995
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
2
Review Days
526
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Basic Information
- Device Name
- DYNATRON 850
- K Number
- K941461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Dynatronics Research Corp.
- Date Received
- March 24, 1994
- Decision Date
- September 1, 1995
- 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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Other Clearances by Dynatronics Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K933249 | DYNATRON 100 PLUS | Oct 8, 1993 | Substantially Equivalent |