Seer Home— 510(k) K212788

Substantially Equivalent

Seer Medical Pty, Ltd.

FDA 510(k) clearance K212788 for Seer Home, Substantially Equivalent on 2022-06-16. Applicant: Seer Medical Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Seer Medical Pty, Ltd.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2021-09-01
Decision date: 2022-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

Download summary PDF View on FDA.gov ↗

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Recalls naming K212788

K-number listed on FDA's recall record

Z-3143-2024 — Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).Class II·Ongoing·SEER MEDICAL PTY LTD·20240812

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212788.

Data sourced from openFDA. This site is unofficial and independent of the FDA.