PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM

Spirometer, Diagnostic

PURITAN BENNETT CORP.

The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett 700 Renaissance Ii Spirometry System.

Pre-market Notification Details

Device IDK022103
510k NumberK022103
Device Name:PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
ClassificationSpirometer, Diagnostic
Applicant PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad,  CA  92008
ContactJames Bonds
CorrespondentJames Bonds
PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad,  CA  92008
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-28
Decision Date2002-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521162164 K022103 000
10884521161832 K022103 000
10884521151673 K022103 000

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