Cleared Traditional

VITALOGRAPH FUNCTION ANALYZER

K791503 · Vitalograph , Ltd. · Anesthesiology
Aug 1979
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K791503 is an FDA 510(k) clearance for the VITALOGRAPH FUNCTION ANALYZER, a Calculator, Pulmonary Function Data (Class II — Special Controls, product code BZC), submitted by Vitalograph , Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979, 8 days after receiving the submission on August 8, 1979. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1880.

Submission Details

510(k) Number K791503 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1979
Decision Date August 16, 1979
Days to Decision 8 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZC — Calculator, Pulmonary Function Data
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1880

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