Spacelabs Medical 90482 Bispectral Index Analysis (Bis) Module

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K973596 ↗

FDA Product Code

OLW

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Spacelabs Medical, Inc. →