FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDILOG VISION
K Number: K961636
·
Decision Jan 17, 1997
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
35
Applicant Total
5
Review Days
263
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Basic Information
- Device Name
- MEDILOG VISION
- K Number
- K961636
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oxford Instruments, Plc.
- Date Received
- April 29, 1996
- Decision Date
- January 17, 1997
- Product Code
- OLZ
- 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 |
|---|---|---|---|
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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