TwitchView System
FDA 510(k) clearance K192958 · decided 2020-04-02
Clearance details
- K-number
- K192958
- Device name
- TwitchView System
- Applicant
- Blink Device Company
- Decision
- Substantially Equivalent
- Date received
- 2019-10-22
- Decision date
- 2020-04-02
- Days to decision
- 163 days
- Clearance type
- Special
- Product code
- KOI
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.