VIGORMIST COMPRESSOR NEBULIZER— 510(k) K031413

Clearance details

Applicant

Vega Technologies, Inc.

Product code

Code BTI

Device class

Class 2

Regulation

21 CFR 868.6250

Advisory panel

Anesthesiology

Date received

2003-05-05

Decision date

2003-10-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taipei, TW

• K131881 — OMBRA TABLE TOP COMPRESSOR2013-10-24
• K113338 — MEDICAL AIR COMPRESSOR2012-08-10
• K091871 — DK50 DS2009-10-23
• K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES2008-11-19
• K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM2006-10-03

• K102625 — VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-032011-06-10
• K102934 — INFRARED EAR THERMOMETER, MODEL IR-04MT2011-01-14
• K102626 — VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC012010-11-12
• K041516 — DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX92004-09-08
• K002831 — VEGA ULTRASONIC NEBULIZER2001-05-23

Death

25

Malfunction

1,168

Total

1,193

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 →

• Z-1720-2015 — Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.Class II·Terminated·Compass Health Brands·20150420

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031413.