Cleared Traditional

7250 METABOLIC MONITOR

K924978 · Puritan Bennett Corp. · Anesthesiology
Sep 1994
Decision
721d
Days
Class 2
Risk

About This 510(k) Submission

K924978 is an FDA 510(k) clearance for the 7250 METABOLIC MONITOR, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on September 22, 1994, 721 days after receiving the submission on October 1, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number K924978 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1992
Decision Date September 22, 1994
Days to Decision 721 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZL — Computer, Oxygen-uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1730