FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMI
K Number: K203827
·
Decision Mar 29, 2021
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
27
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- REMI
- K Number
- K203827
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Epitel, Inc.
- Date Received
- December 29, 2020
- Decision Date
- March 29, 2021
- Product Code
- OMC
- 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 |
|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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