SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842— 510(k) K060900

Name: FDA 510(k) clearance K060900
Creator: U.S. Food and Drug Administration
Published: 2006-06-23

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K060900 for SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842, Substantially Equivalent on 2006-06-23. Applicant: Spacelabs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Product code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2006-04-03
Decision date: 2006-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issaquah, WA, US

Download summary PDF View on FDA.gov ↗

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