Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Menai System

K-Number: K160836 · 2016-12-15

ApplicantResmed, Ltd.
Decision Date2016-12-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Menai System is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K160836. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Menai System?

Menai System is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Resmed, Ltd.. The 510(k) number is K160836.

When did Menai System receive FDA 510(k) clearance?

Menai System received FDA 510(k) clearance on 2016-12-15, under 510(k) number K160836.

Who is the listed applicant for Menai System?

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

What is the FDA product code for Menai System?

The FDA product code for Menai System is BZD.

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.

NCT02811588HomeVent ( Connect) Registry: EU COPD Home NIV RegistryCOMPLETEDNCT07011966ASV Therapy for InsomniaRECRUITINGNCT07336654Circadian Rhythm Monitoring StudyNOT_YET_RECRUITING

Other records listing Resmed, Ltd. 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.

K253553OrionK254104ResScan EssentialsK251889myAirK251657Personalized Therapy Comfort Settings (PTCS)K250624myAirK241939EasyCare Tx 2

View all 22 devices →

Related Devices (Code: BZD)

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.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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.

↑