FDA.report

510(k) K071171

Device
VPAP AUTO WITH H3I
Applicant
Resmed, Ltd.
510(k) number
K071171
Product code
BZD
Decision
Substantially Equivalent (SESE)
Decision date
2007-07-10
Date received
2007-04-27
Regulation
868.5905
Classification name
Ventilator, Non-Continuous (Respirator)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DAVID D'CRUZ
Address
14040 Danielson St. Poway CA US 92064 92064

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00619498249602RPSIIRESMED LIMITED2016-09-29
00619498339594S8RESMED LIMITED2016-09-14
00619498339488S8RESMED LIMITED2016-09-14
00619498339235S8RESMED LIMITED2016-09-14
00619498339198S8RESMED LIMITED2016-09-14
00619498339150S8/ TYPE ARESMED LIMITED2016-09-09

Other 510(k) Records For Product Code BZD

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K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.2026-01-07
K251770SleepRes PAP SystemSleepres, Inc.2025-12-15
K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp2025-12-05
K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited2025-06-18
K250624myAirResmed Corp2025-05-28
K243023WiZARD 520 Full Face MaskWellell, Inc.2025-05-23
K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty , Ltd.2025-05-19
K242935Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.2025-01-15
K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)Genadyne Biotechnologies, Inc.2024-12-31
K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented MaskSleepnet Corporation2024-10-18
K241939EasyCare Tx 2Resmed Corp2024-09-27
K241216myAirResmed Corp2024-09-26