CALDYNE, INC. EXHALOMETER EX100, MODEL EX100

Spirometer, Monitoring (w/wo Alarm)

CALDYNE, INC.

The following data is part of a premarket notification filed by Caldyne, Inc. with the FDA for Caldyne, Inc. Exhalometer Ex100, Model Ex100.

Pre-market Notification Details

Device IDK051279
510k NumberK051279
Device Name:CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
ClassificationSpirometer, Monitoring (w/wo Alarm)
Applicant CALDYNE, INC. 29201 VIA NORTE Temecula,  CA  92591
ContactTom Shanks
CorrespondentTom Shanks
CALDYNE, INC. 29201 VIA NORTE Temecula,  CA  92591
Product CodeBZK  
CFR Regulation Number868.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-17
Decision Date2005-09-07
Summary:summary

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