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FDA 510(k)

PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS

K-Number: K072290 · 2008-05-29

ApplicantDima Italia Srl
Decision Date2008-05-29
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Dima Italia Srl. It received FDA 510(k) clearance on 2008-05-29 under 510(k) number K072290. 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 PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS?

PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS is a medical device that received FDA 510(k) clearance on 2008-05-29. The listed applicant is Dima Italia Srl. The 510(k) number is K072290.

When did PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS receive FDA 510(k) clearance?

PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS received FDA 510(k) clearance on 2008-05-29, under 510(k) number K072290.

Who is the listed applicant for PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS?

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

What is the FDA product code for PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS?

The FDA product code for PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS is BYT.

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.

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Other records listing Dima Italia Srl 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.

K072292NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS

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.

K082657RTX RESPIRATORMedivent LimitedK924341HAYEK 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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