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FDA 510(k)

AIRTRAQ SP AIRTRAQ AVANT

K-Number: K121378 · 2012-06-21

ApplicantProdol Meditec , Ltd.
Decision Date2012-06-21
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRTRAQ SP AIRTRAQ AVANT is the device name listed in this FDA 510(k) record. The listed applicant is Prodol Meditec , Ltd.. It received FDA 510(k) clearance on 2012-06-21 under 510(k) number K121378. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRTRAQ SP AIRTRAQ AVANT?

AIRTRAQ SP AIRTRAQ AVANT is a medical device that received FDA 510(k) clearance on 2012-06-21. The listed applicant is Prodol Meditec , Ltd.. The 510(k) number is K121378.

When did AIRTRAQ SP AIRTRAQ AVANT receive FDA 510(k) clearance?

AIRTRAQ SP AIRTRAQ AVANT received FDA 510(k) clearance on 2012-06-21, under 510(k) number K121378.

Who is the listed applicant for AIRTRAQ SP AIRTRAQ AVANT?

The FDA 510(k) record lists Prodol Meditec , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIRTRAQ SP AIRTRAQ AVANT?

The FDA product code for AIRTRAQ SP AIRTRAQ AVANT is CCW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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