Cleared Traditional

IBT MODEL SVI

K921821 · Biomagnetic Technologies, Inc. · Anesthesiology
Nov 1992
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K921821 is an FDA 510(k) clearance for the IBT MODEL SVI, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Biomagnetic Technologies, Inc. (Newhope, US). The FDA issued a Cleared decision on November 2, 1992, 200 days after receiving the submission on April 16, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K921821 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1992
Decision Date November 02, 1992
Days to Decision 200 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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