SPIROTEQ— 510(k) K894556

Substantially Equivalent

System Analysis Corp.

FDA 510(k) clearance K894556 for SPIROTEQ, Substantially Equivalent on 1990-01-09. Applicant: System Analysis Corp.. Device class: 2.

Clearance details

Applicant: System Analysis Corp.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 1989-07-20
Decision date: 1990-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayes Sous Bois, France, FR

Download summary PDF View on FDA.gov ↗

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