Cleared Traditional

MEDGRAPHICS EXERCISE CONSULT

K923209 · Medical Graphics Corp. · Anesthesiology
Mar 1993
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K923209 is an FDA 510(k) clearance for the MEDGRAPHICS EXERCISE CONSULT, a Calculator, Pulmonary Function Interpretor (diagnostic) (Class II — Special Controls, product code BZM), submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on March 11, 1993, 253 days after receiving the submission on July 1, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number K923209 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1992
Decision Date March 11, 1993
Days to Decision 253 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZM — Calculator, Pulmonary Function Interpretor (diagnostic)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1900

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