FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Nurochek System
K Number: K200705
·
Decision Apr 23, 2020
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
48
Applicant Total
1
Review Days
36
Basic Information
- Device Name
- Nurochek System
- K Number
- K200705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cryptych Pty Ltd
- Date Received
- March 18, 2020
- Decision Date
- April 23, 2020
- Product Code
- GWE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | FDA class 2 | Neurology |
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