FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NTE-2 THERMAL SENSITIVITY TESTER
K Number: K864345
·
Decision Jan 29, 1987
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
5
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NTE-2 THERMAL SENSITIVITY TESTER
- K Number
- K864345
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1200
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Sensortek, Inc.
- Date Received
- November 4, 1986
- Decision Date
- January 29, 1987
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQW), ordered by most recent decision date.
DYNAMIC NEUROSCREENING DEVICE
FDA 510(k)
FDA Class 1
·Neurology
TSA 2001 THERMAL SENSORY ANALYZER
FDA 510(k)
FDA Class 1
·Neurology
Other Clearances by Sensortek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863607 | VIBRATRON II, VIBRATION SENSITIVITY TESTER | Dec 3, 1986 | Substantially Equivalent |
| K852228 | ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS | Sep 3, 1985 | Substantially Equivalent |
| K844056 | THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM | Jan 9, 1985 | Substantially Equivalent |
| K844055 | ESOPHAGEAL STETHO SCOPE | Oct 25, 1984 | Substantially Equivalent |