Atlas FDA

Entropy Module, E-ENTROPY-01

FDA 510(k) clearance K150298 · decided 2015-11-12

Clearance details

K-number
K150298
Device name
Entropy Module, E-ENTROPY-01
Applicant
Ge Healthcare Filand OY
Decision
Substantially Equivalent
Date received
2015-02-06
Decision date
2015-11-12
Days to decision
279 days
Clearance type
Traditional
Product code
OLW
Device class
2
Regulation number
882.1400
Medical specialty
Neurology
Advisory committee
Neurology
Location
Helsinki, FI
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.