FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WAVE GATE
K Number: K853412
·
Decision Oct 28, 1985
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
48
Applicant Total
1
Review Days
76
Basic Information
- Device Name
- WAVE GATE
- K Number
- K853412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- WOLFLINE CORP.
- Date Received
- August 13, 1985
- Decision Date
- October 28, 1985
- Product Code
- GWE
- 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 |
|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | FDA class 2 | Neurology |
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