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FDA 510(k)

NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS

K-Number: K072292 · 2008-01-07

ApplicantDima Italia Srl
Decision Date2008-01-07
Product CodeNHJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEGAVENT PLUS PEGASO COUGH, 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 2008-01-07 under 510(k) number K072292. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS?

NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS is a medical device that received FDA 510(k) clearance on 2008-01-07. The listed applicant is Dima Italia Srl. The 510(k) number is K072292.

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

NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS received FDA 510(k) clearance on 2008-01-07, under 510(k) number K072292.

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

The FDA product code for NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS is NHJ.

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.

K072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS

Related Devices (Code: NHJ)

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.

K260604BiWaze Clear SystemAbmrc, LLCK253001KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)Hunan Ruijiong Biotech Co., Ltd.K242438ClearoBreas Medical ABK231728BiWaze Clear SystemAbmrc, LLCK213564BiWaze Clear SystemAbmrc, LLCK200988Maximus SystemHill-Rom Services Pte, 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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