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510(k) Data Aggregation
K Number
K151357Device Name
MIRI TL
Manufacturer
AT MEDICAL UAB
Date Cleared
2016-04-22
(338 days)
Product Code
MQG, MQK
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
AT MEDICAL UAB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
Preparing, storing and transferring human embryos. To be used only with the MIRI TL device.
Device Description
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K Number
K133742Device Name
XQ-1 INCUBATOR
Manufacturer
AT MEDICAL UAB
Date Cleared
2014-04-23
(135 days)
Product Code
MQG
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
AT MEDICAL UAB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AT MEDICAL XQ-1 Incubator is intended to be used to provide an environment with controlled temperature at or near body temperature and CO2, O2, and N2 gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/ assisted reproduction technology (ART) treatments.
Device Description
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