Cleared Traditional

Model 9100 PFT/DICO

K221030 · Vitalograph (Ireland) , Ltd. · Anesthesiology
Jul 2022
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K221030 is an FDA 510(k) clearance for the Model 9100 PFT/DICO, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Vitalograph (Ireland) , Ltd. (Ennis Co Clare, IE). The FDA issued a Cleared decision on July 15, 2022, 99 days after receiving the submission on April 7, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K221030 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2022
Decision Date July 15, 2022
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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