FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHWAY - ATS/CHEPS
K Number: K052357
·
Decision Jan 19, 2006
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
4
Review Days
143
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Basic Information
- Device Name
- PATHWAY - ATS/CHEPS
- K Number
- K052357
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medoc Ltd. Advanced Medical Systems
- Date Received
- August 29, 2005
- Decision Date
- January 19, 2006
- Product Code
- NTU
- 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 |
|---|---|---|---|
| NTU | Evoked Potential Stimulator, Thermal | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NTU), ordered by most recent decision date.
MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
FDA 510(k)
FDA Class 2
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CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
FDA 510(k)
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