SPM-300— 510(k) K130322

Substantially Equivalent

Bionet Co., Ltd.

FDA 510(k) clearance K130322 for SPM-300, Substantially Equivalent on 2013-11-15. Applicant: Bionet Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bionet Co., Ltd.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2013-02-08
Decision date: 2013-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.