MANTRA COMBO, MODEL MECS 320— 510(k) K091236

Name: FDA 510(k) clearance K091236
Creator: U.S. Food and Drug Administration
Published: 2009-07-30

Substantially Equivalent

Mantra Intl. (Hk) , Ltd.

FDA 510(k) clearance K091236 for MANTRA COMBO, MODEL MECS 320, Substantially Equivalent on 2009-07-30. Applicant: Mantra Intl. (Hk) , Ltd.. Device class: 2.

Clearance details

Applicant: Mantra Intl. (Hk) , Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2009-04-27
Decision date: 2009-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, OH, US

Download summary PDF View on FDA.gov ↗

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