SPIROLAB II, MODEL 29— 510(k) K013812

Substantially Equivalent

Sdi Diagnostics, Inc.

FDA 510(k) clearance K013812 for SPIROLAB II, MODEL 29, Substantially Equivalent on 2002-02-11. Applicant: Sdi Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sdi Diagnostics, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2001-11-15
Decision date: 2002-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Easton, MA, 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.