ASTHMA MONITOR AM3

Spirometer, Diagnostic

ERESEARCH TECHNOLOGY

The following data is part of a premarket notification filed by Eresearch Technology with the FDA for Asthma Monitor Am3.

Pre-market Notification Details

Device IDK133722
510k NumberK133722
Device Name:ASTHMA MONITOR AM3
ClassificationSpirometer, Diagnostic
Applicant ERESEARCH TECHNOLOGY 1818 MARKET STREET, STE 1000 Philadelphia,  PA  19103
ContactRichard A Miller
CorrespondentRichard A Miller
ERESEARCH TECHNOLOGY 1818 MARKET STREET, STE 1000 Philadelphia,  PA  19103
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-05
Decision Date2014-05-08
Summary:summary

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