Home / 510(k) Clearances / K212788

510(k) K212788

Seer Home by Seer Medical Pty, Ltd. — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2022
Date Received
September 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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