Cleared Traditional

PULMONARY MONITOR

K781922 · Vitalograph , Ltd. · Anesthesiology
Feb 1979
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K781922 is an FDA 510(k) clearance for the PULMONARY MONITOR, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Vitalograph , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1979, 92 days after receiving the submission on November 13, 1978. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number K781922 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1978
Decision Date February 13, 1979
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZH — Meter, Peak Flow, Spirometry
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1860

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