MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER— 510(k) K041974

Clearance details

Applicant

Med2000 S.R.L.

Product code

Code BTI

Device class

Class 2

Regulation

21 CFR 868.6250

Advisory panel

Anesthesiology

Date received

2004-07-22

Decision date

2004-08-24

Decision

Substantially Equivalent

Clearance type

Special

Location

Great Neck, NY, US

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• K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM2006-10-03

• K041327 — MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES2004-07-20
• K031908 — MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)2004-01-14

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 →