FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AESCULAP VENTRICULOSCOPE SYSTEM
K Number: K954394
·
Decision Mar 7, 1996
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
207
Review Days
171
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Basic Information
- Device Name
- AESCULAP VENTRICULOSCOPE SYSTEM
- K Number
- K954394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- September 18, 1995
- Decision Date
- March 7, 1996
- Product Code
- GWG
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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