SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE— 510(k) K860689

Name: FDA 510(k) clearance K860689
Creator: U.S. Food and Drug Administration
Published: 1986-07-30

Substantially Equivalent

Spacelabs, Inc.

FDA 510(k) clearance K860689 for SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE, Substantially Equivalent on 1986-07-30. Applicant: Spacelabs, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs, Inc.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 1986-02-25
Decision date: 1986-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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