LUMINEB I— 510(k) K884722

Name: FDA 510(k) clearance K884722
Creator: U.S. Food and Drug Administration
Published: 1989-02-03

Substantially Equivalent

Lumiscope Co., Inc.

FDA 510(k) clearance K884722 for LUMINEB I, Substantially Equivalent on 1989-02-03. Applicant: Lumiscope Co., Inc.. Device class: 2.

Clearance details

Applicant: Lumiscope Co., Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1988-11-10
Decision date: 1989-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, 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 Lumiscope Co., Inc.

view all

K032714 — CARDICARE MODEL MT-301F & MT-301C2003-10-22
K954792 — LUMISCOPE MODEL 2018 THERMOMETER1996-06-21
K931768 — INTERFERENTIAL CURRENT THERAPY UNIT1994-02-23
K925054 — INFRARED LAMP1993-06-29
K924081 — LUMISONIC1992-11-09

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.