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FDA 510(k)

RTX RESPIRATOR

K-Number: K082657 · 2008-10-08

ApplicantMedivent Limited
Decision Date2008-10-08
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RTX RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medivent Limited. It received FDA 510(k) clearance on 2008-10-08 under 510(k) number K082657. The device is classified under product code BYT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTX RESPIRATOR?

RTX RESPIRATOR is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Medivent Limited. The 510(k) number is K082657.

When did RTX RESPIRATOR receive FDA 510(k) clearance?

RTX RESPIRATOR received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082657.

Who is the listed applicant for RTX RESPIRATOR?

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

What is the FDA product code for RTX RESPIRATOR?

The FDA product code for RTX RESPIRATOR is BYT.

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Related Devices (Code: BYT)

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.

K072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia SrlK924341HAYEK OSCILLATOR(TM)Respironics, Inc.K910947NEV-10 NEGATIVE PRESSURE VENTILATORLifecare Services, Inc.K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.K903745THE HAYEK OSCILLATORFlexco Medical Instruments

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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