PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS— 510(k) K072290

Clearance details

Applicant

Dima Italia Srl

Product code

Code BYT

Device class

Class 2

Regulation

21 CFR 868.5935

Advisory panel

Anesthesiology

Date received

2007-08-16

Decision date

2008-05-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Boulder, CO, US

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