Cleared Traditional

1085 ULTIMATE E PLETHYSMOGRAPH

K943259 · Medical Graphics Corp. · Anesthesiology
Apr 1995
Decision
278d
Days
Class 2
Risk

About This 510(k) Submission

K943259 is an FDA 510(k) clearance for the 1085 ULTIMATE E PLETHYSMOGRAPH, a Plethysmograph, Pressure (Class II — Special Controls, product code CCM), submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on April 10, 1995, 278 days after receiving the submission on July 6, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1750.

Submission Details

510(k) Number K943259 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1994
Decision Date April 10, 1995
Days to Decision 278 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCM — Plethysmograph, Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1750