Atlas FDA

NICO BrainPath

FDA 510(k) clearance K172433 · decided 2017-09-07

Clearance details

K-number
K172433
Device name
NICO BrainPath
Applicant
Nico Corporation
Decision
Substantially Equivalent
Date received
2017-08-11
Decision date
2017-09-07
Days to decision
27 days
Clearance type
Special
Product code
GZT
Device class
2
Regulation number
882.4800
Medical specialty
Neurology
Advisory committee
Neurology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.