INFANT FLOW SYSTEM, MODEL M672P

Ventilator, Non-continuous (respirator)

EME (ELECTRO MEDICAL EQUIPMENT) LTD.

The following data is part of a premarket notification filed by Eme (electro Medical Equipment) Ltd. with the FDA for Infant Flow System, Model M672p.

Pre-market Notification Details

Device IDK011516
510k NumberK011516
Device Name:INFANT FLOW SYSTEM, MODEL M672P
ClassificationVentilator, Non-continuous (respirator)
Applicant EME (ELECTRO MEDICAL EQUIPMENT) LTD. 60 GLADSTONE PLACE Brighton, Sussex,  GB Bn2 3qd
ContactStuart Corner
CorrespondentStuart Corner
EME (ELECTRO MEDICAL EQUIPMENT) LTD. 60 GLADSTONE PLACE Brighton, Sussex,  GB Bn2 3qd
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-17
Decision Date2001-06-08

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