Cleared Special

PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM

K022103 · Puritan Bennett Corp. · Anesthesiology
Sep 2002
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K022103 is an FDA 510(k) clearance for the PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on September 27, 2002, 91 days after receiving the submission on June 28, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K022103 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2002
Decision Date September 27, 2002
Days to Decision 91 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840