ASCOM MOBILE MONITORING GATEWAY (MMG)

System, Network And Communication, Physiological Monitors

ASCOM (SWEDEN) AB

The following data is part of a premarket notification filed by Ascom (sweden) Ab with the FDA for Ascom Mobile Monitoring Gateway (mmg).

Pre-market Notification Details

Device IDK111215
510k NumberK111215
Device Name:ASCOM MOBILE MONITORING GATEWAY (MMG)
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant ASCOM (SWEDEN) AB GRIMBODALEN 2, P.O. BOX 8783 Goteborg,  SE Se-402-76
ContactTania Ottebrink
CorrespondentTania Ottebrink
ASCOM (SWEDEN) AB GRIMBODALEN 2, P.O. BOX 8783 Goteborg,  SE Se-402-76
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-02
Decision Date2011-07-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17350088670009 K111215 000

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