Atlas FDA

TwitchView System

FDA 510(k) clearance K172843 · decided 2018-03-29

Clearance details

K-number
K172843
Device name
TwitchView System
Applicant
Blink Device Corporation
Decision
Substantially Equivalent
Date received
2017-09-19
Decision date
2018-03-29
Days to decision
191 days
Clearance type
Traditional
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.