FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
K Number: K963669
·
Decision Dec 12, 1996
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM
- K Number
- K963669
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astro-Med, Inc.
- Date Received
- September 13, 1996
- Decision Date
- December 12, 1996
- Product Code
- GWL
- 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 |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | FDA class 2 | Neurology |
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