SPIROSIFT 500A— 510(k) K904200

Substantially Equivalent

Fukuda Denshi USA, Inc.

FDA 510(k) clearance K904200 for SPIROSIFT 500A, Substantially Equivalent on 1991-05-22. Applicant: Fukuda Denshi USA, Inc.. Device class: 2.

Clearance details

Applicant: Fukuda Denshi USA, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1990-09-12
Decision date: 1991-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.