FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
R-40 EEG Amplifier
K Number: K151600
·
Decision Oct 23, 2015
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
4
Review Days
133
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Basic Information
- Device Name
- R-40 EEG Amplifier
- K Number
- K151600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lifelines , Ltd.
- Date Received
- June 12, 2015
- Decision Date
- October 23, 2015
- 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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