Cleared Traditional

SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001

K020641 · Worldwide Medical Technologies, LLC · Anesthesiology
Oct 2002
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K020641 is an FDA 510(k) clearance for the SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Worldwide Medical Technologies, LLC (Waycross, US). The FDA issued a Cleared decision on October 29, 2002, 244 days after receiving the submission on February 27, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K020641 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2002
Decision Date October 29, 2002
Days to Decision 244 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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