SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE— 510(k) K973596

Name: FDA 510(k) clearance K973596
Creator: U.S. Food and Drug Administration
Published: 1998-02-03

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K973596 for SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE, Substantially Equivalent on 1998-02-03. Applicant: Spacelabs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1997-09-22
Decision date: 1998-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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