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FDA 510(k)

DYNA-EXTOR II

K-Number: K110426 · 2011-11-02

ApplicantBk Meditech, Co., Ltd.
Decision Date2011-11-02
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNA-EXTOR II is the device name listed in this FDA 510(k) record. The listed applicant is Bk Meditech, Co., Ltd.. It received FDA 510(k) clearance on 2011-11-02 under 510(k) number K110426. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNA-EXTOR II?

DYNA-EXTOR II is a medical device that received FDA 510(k) clearance on 2011-11-02. The listed applicant is Bk Meditech, Co., Ltd.. The 510(k) number is K110426.

When did DYNA-EXTOR II receive FDA 510(k) clearance?

DYNA-EXTOR II received FDA 510(k) clearance on 2011-11-02, under 510(k) number K110426.

Who is the listed applicant for DYNA-EXTOR II?

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

What is the FDA product code for DYNA-EXTOR II?

The FDA product code for DYNA-EXTOR II is KTT.

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Related Devices (Code: KTT)

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Official Source

View on FDA Database →

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

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