Cleared Traditional

FLOWSCREEN

K932744 · Erich Jaeger, Inc. · Anesthesiology
Mar 1994
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K932744 is an FDA 510(k) clearance for the FLOWSCREEN, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on March 7, 1994, 272 days after receiving the submission on June 8, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K932744 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1993
Decision Date March 07, 1994
Days to Decision 272 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTY — Calculator, Predicted Values, Pulmonary Function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890

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