Cleared Traditional

K960078 - ASTHMA MONITOR
(FDA 510(k) Clearance)

K960078 · Erich Jaeger, Inc. · Anesthesiology
Sep 1996
Decision
259d
Days
Class 2
Risk

K960078 is an FDA 510(k) clearance for the ASTHMA MONITOR. This device is classified as a Spirometer, Diagnostic (Class II — Special Controls, product code BZG).

Submitted by Erich Jaeger, Inc. (Hoechberg, Germany, DE). The FDA issued a Cleared decision on September 20, 1996, 259 days after receiving the submission on January 5, 1996.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K960078 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1996
Decision Date September 20, 1996
Days to Decision 259 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840