Cleared Traditional

VITALOGRAPH DATA STORAGE SPIROMETER

K930085 · Vitalograph , Ltd. · Anesthesiology
Jul 1993
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K930085 is an FDA 510(k) clearance for the VITALOGRAPH DATA STORAGE SPIROMETER, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on July 26, 1993, 200 days after receiving the submission on January 7, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K930085 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1993
Decision Date July 26, 1993
Days to Decision 200 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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