FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GSA GENITO SENSORY ANALYZER
K Number: K010981
·
Decision Sep 20, 2001
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
12
Applicant Total
4
Review Days
171
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Basic Information
- Device Name
- GSA GENITO SENSORY ANALYZER
- K Number
- K010981
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1200
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medoc Ltd. Advanced Medical Systems
- Date Received
- April 2, 2001
- Decision Date
- September 20, 2001
- Product Code
- LLN
- 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 |
|---|---|---|---|
| LLN | Device, Vibration Threshold Measurement | FDA class 1 | Neurology |
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