Cleared Traditional

PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE

K944762 · Puritan Bennett Corp. · Anesthesiology

Dec 1994

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K944762 is an FDA 510(k) clearance for the PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Puritan Bennett Corp. (Wilmington, US). The FDA issued a Cleared decision on December 13, 1994, 77 days after receiving the submission on September 27, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number	K944762 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 1994
Decision Date	December 13, 1994
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF