SPIROTEL, MODEL 29-1020— 510(k) K031643

Substantially Equivalent

Sdi Diagnostics, Inc.

FDA 510(k) clearance K031643 for SPIROTEL, MODEL 29-1020, Substantially Equivalent on 2003-12-09. Applicant: Sdi Diagnostics, Inc..

Clearance details

Applicant: Sdi Diagnostics, Inc.
Product code: Code BZG
Advisory panel: Anesthesiology
Date received: 2003-05-27
Decision date: 2003-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Easton, MA, US

Download summary PDF View on FDA.gov ↗

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