MEDI-MIST PORTA. COMPRESSOR DRIVEN— 510(k) K833501

Name: FDA 510(k) clearance K833501
Creator: U.S. Food and Drug Administration
Published: 1983-12-12

Substantially Equivalent

Mountain Medical Equipment, Inc.

FDA 510(k) clearance K833501 for MEDI-MIST PORTA. COMPRESSOR DRIVEN, Substantially Equivalent on 1983-12-12. Applicant: Mountain Medical Equipment, Inc.. Device class: 2.

Clearance details

Applicant: Mountain Medical Equipment, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1983-10-05
Decision date: 1983-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTI

view all

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

More clearances from Mountain Medical Equipment, Inc.

view all

K941793 — OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)1995-06-21
K923650 — SCOTTY1993-01-15
K924684 — MICROFLOW1992-12-15
K914916 — ALPINE V1992-09-23
K902890 — ASPEN 3 OXYGEN CONCENTRATOR1990-07-19

Adverse events under product code BTI

product code BTI

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.