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510(k) K213299

Device
Wireless EEG System
Applicant
Pascall Systems Inc
510(k) number
K213299
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-11
Date received
2021-10-01
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tuan Le Mau
Address
200 Portland St. Boston MA US 02114 02114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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