CereTom Elite
K-Number: K172539 · 2017-11-22
Decision Date2017-11-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CereTom Elite is a medical device manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. It received FDA 510(k) clearance on 2017-11-22 under approval number K172539. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CereTom Elite?
CereTom Elite is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. The 510(k) number is K172539.
When was CereTom Elite approved by the FDA?
CereTom Elite received FDA 510(k) clearance on 2017-11-22, under approval number K172539.
What company makes CereTom Elite?
CereTom Elite is manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics.
What is the FDA product code for CereTom Elite?
The FDA product code for CereTom Elite is JAK.
Other Devices by Neurologica Corporation, A Subsidiary of Samsung Electronics
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.