PULMO-MIST COMPRESSOR MODEL # 4323— 510(k) K020797

Clearance details

Applicant

Nidek Medical Products, Inc.

Product code

Code BTI

Device class

Class 2

Regulation

21 CFR 868.6250

Advisory panel

Anesthesiology

Date received

2002-03-12

Decision date

2002-05-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Birmingham, AL, US

• 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

• K192693 — Nuvo Nano Portable Oxygen Concentrator2020-05-07
• K123738 — MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD2013-02-28
• K093308 — MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD2010-01-14
• K082566 — MARK 5 NUVO LITE OCSI AND STD2008-12-03
• K040892 — MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 9052004-04-29

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 →