PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE— 510(k) K944762

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K944762 for PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE, Substantially Equivalent on 1994-12-13. Applicant: Puritan Bennett Corp.. Device class: 2.

Clearance details

Applicant
Puritan Bennett Corp.
Product code
Code BZG
Device class
Class 2
Regulation
21 CFR 868.1840
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wilmington, MA, US
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