AIR PLUS NEBULIZER— 510(k) K902520

Name: FDA 510(k) clearance K902520
Creator: U.S. Food and Drug Administration
Published: 1991-03-04

Substantially Equivalent

Diamond Medical Equipment, Inc.

FDA 510(k) clearance K902520 for AIR PLUS NEBULIZER, Substantially Equivalent on 1991-03-04. Applicant: Diamond Medical Equipment, Inc.. Device class: 2.

Clearance details

Applicant: Diamond Medical Equipment, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1990-06-07
Decision date: 1991-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamaica, NY, 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 Diamond Medical Equipment, Inc.

view all

K891259 — MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD1989-11-17
K883188 — T.E.N.S. UNIT SIGMA & TX-31988-12-16

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.