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FDA 510(k)

DuoFLEX Coil Suite

K-Number: K173290 · 2017-11-28

ApplicantMr Instruments, Inc.
Decision Date2017-11-28
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DuoFLEX Coil Suite is the device name listed in this FDA 510(k) record. The listed applicant is Mr Instruments, Inc.. It received FDA 510(k) clearance on 2017-11-28 under 510(k) number K173290. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DuoFLEX Coil Suite?

DuoFLEX Coil Suite is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is Mr Instruments, Inc.. The 510(k) number is K173290.

When did DuoFLEX Coil Suite receive FDA 510(k) clearance?

DuoFLEX Coil Suite received FDA 510(k) clearance on 2017-11-28, under 510(k) number K173290.

Who is the listed applicant for DuoFLEX Coil Suite?

The FDA 510(k) record lists Mr Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuoFLEX Coil Suite?

The FDA product code for DuoFLEX Coil Suite is MOS.

Related Devices (Code: MOS)

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.

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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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