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)

APNEALINK PRO

K-Number: K131932 · 2013-11-08

ApplicantResmed Germany, Inc.
Decision Date2013-11-08
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

APNEALINK PRO is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Germany, Inc.. It received FDA 510(k) clearance on 2013-11-08 under 510(k) number K131932. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APNEALINK PRO?

APNEALINK PRO is a medical device that received FDA 510(k) clearance on 2013-11-08. The listed applicant is Resmed Germany, Inc.. The 510(k) number is K131932.

When did APNEALINK PRO receive FDA 510(k) clearance?

APNEALINK PRO received FDA 510(k) clearance on 2013-11-08, under 510(k) number K131932.

Who is the listed applicant for APNEALINK PRO?

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

What is the FDA product code for APNEALINK PRO?

The FDA product code for APNEALINK PRO is MNR.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Resmed Germany, 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.

K122715STELLAR 150K113640STELLAR 150K103167STELLAR 150K083575APNEALINK PLUS, MODEL: 22328K070263APNEALINKK061405APNEALINK, MODEL 22302

View all 7 devices →

Related Devices (Code: MNR)

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.

K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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.

↑