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510(k) K854030

WRIST ACTIGRAPH by Ambulatory Monitoring, Inc. — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1986
Date Received
October 1, 1985
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

Other clearances by Ambulatory Monitoring, Inc.

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  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
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