FDA 510(k)

Basic, Dominant Flex

K-Number: K170329 · 2017-03-24

Decision Date2017-03-24

Product CodeQPB

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Basic, Dominant Flex is the device name listed in this FDA 510(k) record. The listed applicant is Modela AG. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K170329. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Basic, Dominant Flex?

Basic, Dominant Flex is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Modela AG. The 510(k) number is K170329.

When did Basic, Dominant Flex receive FDA 510(k) clearance?

Basic, Dominant Flex received FDA 510(k) clearance on 2017-03-24, under 510(k) number K170329.

Who is the listed applicant for Basic, Dominant Flex?

The FDA 510(k) record lists Modela AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Basic, Dominant Flex?

The FDA product code for Basic, Dominant Flex is QPB.

Related Devices (Code: QPB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251944Lipocosm Harmonic SystemLipocosm, LLC K253396AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical Corporation K252495LSSA (NP-200)Newpong Co., Ltd.K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation K244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLC K242804PAL Aspiration SystemMicroaire Surgical Instruments, LLC

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.