FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WIRELESS EEG RECORDING SYSTEM MODEL W32
K Number: K963195
·
Decision Jul 29, 1997
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
19
Applicant Total
1
Review Days
348
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Basic Information
- Device Name
- WIRELESS EEG RECORDING SYSTEM MODEL W32
- K Number
- K963195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1855
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cme Telemetrix, Inc.
- Date Received
- August 15, 1996
- Decision Date
- July 29, 1997
- Product Code
- GYE
- 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 |
|---|---|---|---|
| GYE | Encephalogram Telemetry System | FDA class 2 | Neurology |
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