MPM SYSTEM

System, Measurement, Blood-pressure, Non-invasive

AEROTEL MEDICAL SYSTEMS, LTD.

The following data is part of a premarket notification filed by Aerotel Medical Systems, Ltd. with the FDA for Mpm System.

Pre-market Notification Details

Device IDK041854
510k NumberK041854
Device Name:MPM SYSTEM
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant AEROTEL MEDICAL SYSTEMS, LTD. 377 ROUTE 17 S Hasbrouck Heights,  NJ  07604
ContactGeorge Myers
CorrespondentGeorge Myers
AEROTEL MEDICAL SYSTEMS, LTD. 377 ROUTE 17 S Hasbrouck Heights,  NJ  07604
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-08
Decision Date2004-10-06
Summary:summary

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