Cleared Traditional

APNOESCREEN PRO, ALPHA SCREEN PRO

K000396 · Erich Jaeger, Inc. · Anesthesiology
Dec 2000
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K000396 is an FDA 510(k) clearance for the APNOESCREEN PRO, ALPHA SCREEN PRO, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Erich Jaeger, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on December 27, 2000, 324 days after receiving the submission on February 7, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K000396 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2000
Decision Date December 27, 2000
Days to Decision 324 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375