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FDA 510(k)

RES TRAXX ONLINE, MODEL: R14

K-Number: K083816 · 2009-03-20

ApplicantResmed, Ltd.
Decision Date2009-03-20
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RES TRAXX ONLINE, MODEL: R14 is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2009-03-20 under 510(k) number K083816. 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 RES TRAXX ONLINE, MODEL: R14?

RES TRAXX ONLINE, MODEL: R14 is a medical device that received FDA 510(k) clearance on 2009-03-20. The listed applicant is Resmed, Ltd.. The 510(k) number is K083816.

When did RES TRAXX ONLINE, MODEL: R14 receive FDA 510(k) clearance?

RES TRAXX ONLINE, MODEL: R14 received FDA 510(k) clearance on 2009-03-20, under 510(k) number K083816.

Who is the listed applicant for RES TRAXX ONLINE, MODEL: R14?

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 RES TRAXX ONLINE, MODEL: R14?

The FDA product code for RES TRAXX ONLINE, MODEL: R14 is BZD.

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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.

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