FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERVOTRONIC EC100 SYSTEM
K Number: K972857
·
Decision Jan 16, 1998
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
25
Applicant Total
17
Review Days
168
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Basic Information
- Device Name
- SERVOTRONIC EC100 SYSTEM
- K Number
- K972857
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4360
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicon EG
- Date Received
- August 1, 1997
- Decision Date
- January 16, 1998
- Product Code
- HBC
- 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 |
|---|---|---|---|
| HBC | Motor, Drill, Electric | FDA class 2 | Neurology |
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