Cleared Traditional

ALVEO-DIFFUSION TEST

K853443 · Erich Jaeger, Inc. · Anesthesiology
Feb 1986
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K853443 is an FDA 510(k) clearance for the ALVEO-DIFFUSION TEST, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on February 21, 1986, 189 days after receiving the submission on August 16, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number K853443 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1985
Decision Date February 21, 1986
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZC — Calculator, Pulmonary Function Data
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1880

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