AIR-BAG SYSTEM— 510(k) K112969

Substantially Equivalent

Niigata Mechatronics Co., Ltd.

FDA 510(k) clearance K112969 for AIR-BAG SYSTEM, Substantially Equivalent on 2012-03-14. Applicant: Niigata Mechatronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Niigata Mechatronics Co., Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2011-10-05
Decision date: 2012-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niigata-City, JP

Download summary PDF View on FDA.gov ↗

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