Cleared Traditional

Vitalograph Model 2120 In2itive eDiary

K200550 · Vitalograph (Ireland) , Ltd. · Anesthesiology
Jul 2020
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K200550 is an FDA 510(k) clearance for the Vitalograph Model 2120 In2itive eDiary, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Vitalograph (Ireland) , Ltd. (Ennis Co Clare, IE). The FDA issued a Cleared decision on July 27, 2020, 146 days after receiving the submission on March 3, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K200550 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2020
Decision Date July 27, 2020
Days to Decision 146 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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