Wireless EEG System
K-Number: K213299 · 2022-05-11
ApplicantPascall Systems, Inc.
Decision Date2022-05-11
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Wireless EEG System is a medical device manufactured by Pascall Systems, Inc.. It received FDA 510(k) clearance on 2022-05-11 under approval number K213299. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Wireless EEG System?
Wireless EEG System is a medical device that received FDA 510(k) clearance on 2022-05-11. It is manufactured by Pascall Systems, Inc.. The 510(k) number is K213299.
When was Wireless EEG System approved by the FDA?
Wireless EEG System received FDA 510(k) clearance on 2022-05-11, under approval number K213299.
What company makes Wireless EEG System?
Wireless EEG System is manufactured by Pascall Systems, Inc..
What is the FDA product code for Wireless EEG System?
The FDA product code for Wireless EEG System is OLT.
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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.