AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)

K001137 · Trudell Medical Int'L · CAF · Jul 5, 2000 · Anesthesiology

Device Facts

Record IDK001137
Device NameAEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
ApplicantTrudell Medical Int'L
Product CodeCAF · Anesthesiology
Decision DateJul 5, 2000
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 868.5630
Device ClassClass 2

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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