FDA 510(k)

VPAP ST

K-Number: K080131 · 2008-04-01

Decision Date2008-04-01

Product CodeBZD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VPAP ST is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2008-04-01 under 510(k) number K080131. 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 ST?

VPAP ST is a medical device that received FDA 510(k) clearance on 2008-04-01. The listed applicant is Resmed, Ltd.. The 510(k) number is K080131.

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

VPAP ST received FDA 510(k) clearance on 2008-04-01, under 510(k) number K080131.

Who is the listed applicant for VPAP ST?

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 VPAP ST?

The FDA product code for VPAP ST is BZD.

Other records listing Resmed, Ltd. as applicant

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Related Devices (Code: BZD)

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed Corp K254104ResScan EssentialsResmed Corp K251920Sleep 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.