FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
TSA 2001 THERMAL SENSORY ANALYZER
K Number: K922052
·
Decision Oct 21, 1993
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
1
Review Days
535
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Basic Information
- Device Name
- TSA 2001 THERMAL SENSORY ANALYZER
- K Number
- K922052
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1200
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medoc Corp.
- Date Received
- May 4, 1992
- Decision Date
- October 21, 1993
- Product Code
- LQW
- 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 |
|---|---|---|---|
| LQW | Test, Temperature Discrimination | FDA class 1 | Neurology |
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