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510(k) Data Aggregation

    K Number
    K121566
    Device Name
    PLANER BT37 INCUBATOR
    Manufacturer
    PLANER PLC
    Date Cleared
    2012-11-29

    (184 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANER PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planer BT37 Incubator is intended to be used to provide an environment with controlled temperature at or near body temperature, CO2, O2 and N2 gases, and elevated humidity for the development of gametes and embryos during in vitro fertilization (IVF) / assisted reproductive technology (ART) treatments.
    Device Description
    The BT37 Incubator has been designed as a bench-top incubator to provide a electronically controlled environment (temperature and humidified-gas (premixed gas; typically 6% CO2, 5% O2, balance N2)) for use in cell culture as part of In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments. The BT37 Incubator overall dimensions are 420mm wide x 270mm deep x 210mm high, with a weight of 15,5 kg. The BT37 Incubator has two chambers each of which have been designed to hold a variety of dishes. In case of external power failure, the BT37 incubator is equipped with an internal backup battery to maintain functionality for up to 120 minutes. The BT37 Incubator provides an environment with elevated humidity by bubbling the incoming gas through a heated humidification bottle containing water. This gas this then passed to the left and right incubation chambers. In its default configuration, the BT37 normally provides gas at a constant flow rate of 30 mL/min. After closing the lids, an increased gas flow at 360 ml./min is provided for 3 minutes to purge the systems. After fitting a new bottle, a triple length purge of 360 ml /min for 9 minutes is provided. An alternative pulsed flow regime is available, where the normally constant flow of 30 mL/min can be replaced by a flow that pulses between a high and low rate. The default for these settings are normally 60 mL/min and 20 mL/min respectively with a time ratio designed to provide a mean flow of 30 mL/min. This flow approach is not normally used.
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    K Number
    K032086
    Device Name
    KRYO ART CONTROLLED RATE FREEZER
    Manufacturer
    PLANER PLC
    Date Cleared
    2004-03-19

    (256 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANER PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kryo ART brand of controlled rate freezers are intended to be used to freeze gametes or embryos at a user determined rate.
    Device Description
    The Kryo ART range of controlled rate freezers have been specifically designed and configured for use in the assisted reproduction field. The Kryo ART range of controlled rate freezers are available in three chamber sizes depending on the number of samples to be frozen; 1.7 liters, 3.3 liters and 16 liters. All models incorporate the critical features expected from a high specification biological chamber and the -180 degrees C to +40 degrees C temperature range allows flexibility for a wide range of applications and protocols. All of the chamber sizes are controlled by the MRV controller system, which has been created to offer multiple protocols while remaining simple to program and operate. All systems include power failure protection, which allows the controller to continue monitoring during mains power failures. All software is designed, developed and maintained in accordance with the Company's internal procedures. These procedures form part of the full Quality System, which is approved to ISO 9001:1994, ISO 13485:1996 and EN 46001:1996. Performance testing is complete. Units were tested according to a specific protocol. Testing demonstrates the functional suitability of the Kryo ART Controlled Rate Freezer for their intended purpose. The Kryo ART brand of controlled rate freezes are intended to freeze gametes or embryos at a user determined rate.
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