FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cadwell AmpliScan
K Number: K161027
·
Decision Nov 8, 2016
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
15
Applicant Total
12
Review Days
210
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Basic Information
- Device Name
- Cadwell AmpliScan
- K Number
- K161027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cadwell Industries, Inc.
- Date Received
- April 12, 2016
- Decision Date
- November 8, 2016
- Product Code
- OMA
- 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 |
|---|---|---|---|
| OMA | Amplitude-Integrated Electroencephalograph | FDA class 2 | Neurology |
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