Cleared Traditional

VITALOGRAPH SPIROTRAC III

K912412 · Vitalograph , Ltd. · Anesthesiology
Oct 1991
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K912412 is an FDA 510(k) clearance for the VITALOGRAPH SPIROTRAC III, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on October 15, 1991, 137 days after receiving the submission on May 31, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K912412 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1991
Decision Date October 15, 1991
Days to Decision 137 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840