FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TwitchView System
K Number: K172843
·
Decision Mar 29, 2018
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
28
Applicant Total
1
Review Days
191
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Basic Information
- Device Name
- TwitchView System
- K Number
- K172843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blink Device Corporation
- Date Received
- September 19, 2017
- Decision Date
- March 29, 2018
- Product Code
- KOI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| KOI | Stimulator, Nerve, Peripheral, Electric | FDA class 2 | Anesthesiology |
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