SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER— 510(k) K905458

Name: FDA 510(k) clearance K905458
Creator: U.S. Food and Drug Administration
Published: 1991-02-07

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K905458 for SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER, Substantially Equivalent on 1991-02-07. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DQE
Device class: Class 2
Regulation: 21 CFR 870.1230
Advisory panel: Cardiovascular
Date received: 1990-12-05
Decision date: 1991-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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