FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Modified BrainScope One
K Number: K181785
·
Decision Dec 19, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
8
Applicant Total
8
Review Days
169
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Basic Information
- Device Name
- Modified BrainScope One
- K Number
- K181785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1450
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brainscope Company, Inc.
- Date Received
- July 3, 2018
- Decision Date
- December 19, 2018
- Product Code
- PIW
- 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 |
|---|---|---|---|
| PIW | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | FDA class 2 | Neurology |
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Other Clearances by Brainscope Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190815 | BrainScope TBI | Sep 11, 2019 | Substantially Equivalent |
| K183241 | BrainScope TBI (Model: Ahead 400) | Feb 19, 2019 | Substantially Equivalent |
| K181179 | BrainScope One | May 18, 2018 | Substantially Equivalent |
| K161068 | Ahead 300 | Sep 22, 2016 | Substantially Equivalent |
| K143643 | Brainscope Ahead 200 | May 15, 2015 | Substantially Equivalent |
| DEN140025 | BrainScope Ahead 100 | Nov 17, 2014 | Unknown |
| K082886 | ZOOM-100DC | Aug 10, 2009 | Substantially Equivalent |