NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS— 510(k) K072292

Clearance details

Applicant

Dima Italia Srl

Product code

Code NHJ

Device class

Class 2

Regulation

21 CFR 868.5905

Advisory panel

Anesthesiology

Date received

2007-08-16

Decision date

2008-01-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Boulder, CO, US

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• K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC2014-10-16
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• K072290 — PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS2008-05-29

Death

7

Total

7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →