FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
K Number: K963202
·
Decision May 19, 1997
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
4
Review Days
277
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Basic Information
- Device Name
- MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
- K Number
- K963202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mega Electronics , Ltd.
- Date Received
- August 15, 1996
- Decision Date
- May 19, 1997
- Product Code
- HCC
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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