PH-100, MODEL 2104

Media, Reproductive

VITROLIFE SWEDEN AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Ph-100, Model 2104.

Pre-market Notification Details

Device IDK991346
510k NumberK991346
Device Name:PH-100, MODEL 2104
ClassificationMedia, Reproductive
Applicant VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg,  SE Se-412 63
ContactEiler Anderson
CorrespondentEiler Anderson
VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg,  SE Se-412 63
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-19
Decision Date2000-02-24
Summary:summary

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