Atlas FDA

QAF

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Impedance Plethysmograph, Cranial
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Medical specialty
Cardiovascular
FDA definition
Detect or measure variations in volume in the cranium, using tissue impedance properties.
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RecordFirmDate
STEDI Scan Device (K253840)Stroke DX2026-07-22
Visor System (K182967)Cerebrotech Medical Systems, Inc.2018-11-23
Cerebrotech CMS-5000 (K171186)Cerebrotech Medical Systems2017-12-08

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Every clearance here is in the API, with alerts when new ones post.