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FDA 510(k)

Monarch Platform

K-Number: K193534 · 2020-04-15

ApplicantAuris Health, Inc.
Decision Date2020-04-15
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Monarch Platform is the device name listed in this FDA 510(k) record. The listed applicant is Auris Health, Inc.. It received FDA 510(k) clearance on 2020-04-15 under 510(k) number K193534. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monarch Platform?

Monarch Platform is a medical device that received FDA 510(k) clearance on 2020-04-15. The listed applicant is Auris Health, Inc.. The 510(k) number is K193534.

When did Monarch Platform receive FDA 510(k) clearance?

Monarch Platform received FDA 510(k) clearance on 2020-04-15, under 510(k) number K193534.

Who is the listed applicant for Monarch Platform?

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

What is the FDA product code for Monarch Platform?

The FDA product code for Monarch Platform is EOQ.

Related Clinical Trials

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.

NCT06709261Safety and Performance of the OTTAVA Robotic SystemCOMPLETEDNCT07298317Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia RepairRECRUITING

Other records listing Auris Health, Inc. as applicant

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.

K260382MONARCH™ Platform (MON-000008)K243219MONARCH™ Platform (MON-000008)K213334Monarch Platform, UrologyK211493Monarch Platform

Related Devices (Code: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.

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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