Cleared Traditional

VITALOGRAPH COMPACT

K854526 · Vitalograph , Ltd. · Anesthesiology
Dec 1985
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K854526 is an FDA 510(k) clearance for the VITALOGRAPH COMPACT, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on December 24, 1985, 41 days after receiving the submission on November 13, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K854526 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1985
Decision Date December 24, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

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