Cleared Traditional

VITALOGRAPH PFT PRINTER

K823683 · Vitalograph , Ltd. · Anesthesiology
Jan 1983
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K823683 is an FDA 510(k) clearance for the VITALOGRAPH PFT PRINTER, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Vitalograph , Ltd. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983, 45 days after receiving the submission on December 7, 1982. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K823683 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 1982
Decision Date January 21, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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