Cleared Traditional

ERIE-NEB

K861865 · Erie Medical · Anesthesiology
Jul 1986
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K861865 is an FDA 510(k) clearance for the ERIE-NEB, a Compressor, Air, Portable (Class II — Special Controls, product code BTI), submitted by Erie Medical (Milwaukee, US). The FDA issued a Cleared decision on July 1, 1986, 47 days after receiving the submission on May 15, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number K861865 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1986
Decision Date July 01, 1986
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTI — Compressor, Air, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.6250