FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
SENSITESTER
K Number: K871167
·
Decision Apr 1, 1987
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
4
Applicant Total
1
Review Days
8
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
- SENSITESTER
- K Number
- K871167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1750
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Dexin Pty. , Ltd.
- Date Received
- March 24, 1987
- Decision Date
- April 1, 1987
- Product Code
- GWY
- 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 |
|---|---|---|---|
| GWY | Pinwheel | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWY), ordered by most recent decision date.
BIS SRS (SEMI-RESUABLE SENSOR)
FDA 510(k)
FDA Class 1
·Neurology
NEURO-AIDE
FDA 510(k)
FDA Class 1
·Neurology
1-380 PINWHEEL (WARTENBERG)
FDA 510(k)
FDA Class 1
·Neurology
PINWHEEL
FDA 510(k)
FDA Class 1
·Neurology