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)

VPAP ADAPT

K-Number: K113801 · 2012-05-25

ApplicantResmed Corp
Decision Date2012-05-25
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VPAP ADAPT is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2012-05-25 under 510(k) number K113801. 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 VPAP ADAPT?

VPAP ADAPT is a medical device that received FDA 510(k) clearance on 2012-05-25. The listed applicant is Resmed Corp. The 510(k) number is K113801.

When did VPAP ADAPT receive FDA 510(k) clearance?

VPAP ADAPT received FDA 510(k) clearance on 2012-05-25, under 510(k) number K113801.

Who is the listed applicant for VPAP ADAPT?

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

What is the FDA product code for VPAP ADAPT?

The FDA product code for VPAP ADAPT 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.

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 Corp 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.

K261360EasyCare Tx 2K253553OrionK254104ResScan EssentialsK251889myAirK251657Personalized Therapy Comfort Settings (PTCS)K250624myAir

View all 17 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.

K261262Altis Full Face MaskRespironics, Inc.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.

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.

↑