VENTILAIR II MEDICAL AIR COMPRESSOR— 510(k) K041781

Clearance details

Applicant

Hamilton Medical AG

Product code

Code BTI

Device class

Class 2

Regulation

21 CFR 868.6250

Advisory panel

Anesthesiology

Date received

2004-07-01

Decision date

2005-03-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Reno, NV, 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

• K201306 — HAMILTON-C32021-02-05
• K201658 — Hamilton-C62020-12-11
• K193228 — Hamilton-G52020-05-04
• K181216 — HAMILTON-T1, HAMILTON-C12019-08-02
• K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC40102017-09-20

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 →