Cleared Abbreviated

PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE

K023225 · Puritan Bennett Corp. · Anesthesiology
Dec 2002
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K023225 is an FDA 510(k) clearance for the PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Puritan Bennett Corp. (Pleasanton, US). The FDA issued a Cleared decision on December 18, 2002, 82 days after receiving the submission on September 27, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K023225 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2002
Decision Date December 18, 2002
Days to Decision 82 days
Submission Type Abbreviated
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