ERIE-NEB— 510(k) K861865

Name: FDA 510(k) clearance K861865
Creator: U.S. Food and Drug Administration
Published: 1986-07-01

Substantially Equivalent

Erie Medical

FDA 510(k) clearance K861865 for ERIE-NEB, Substantially Equivalent on 1986-07-01. Applicant: Erie Medical. Device class: 2.

Clearance details

Applicant: Erie Medical
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1986-05-15
Decision date: 1986-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES2008-11-19
K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM2006-10-03

More clearances from Erie Medical

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K853039 — PRESSURE REGULATOR1986-04-11
K853051 — TRACHEAL TUBES1986-04-11
K853040 — PRESSURE GAUGE1985-10-10
K832466 — TRACHEAL TUBE 16 GAUGE-1.65MM-1984-09-19

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.