LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K963620
    Device Name
    9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
    Manufacturer
    9TH WAVE, INC.
    Date Cleared
    1997-01-07

    (119 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    9TH WAVE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K963626
    Device Name
    9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
    Manufacturer
    9TH WAVE, INC.
    Date Cleared
    1996-11-26

    (76 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    9TH WAVE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K963677
    Device Name
    9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
    Manufacturer
    9TH WAVE, INC.
    Date Cleared
    1996-11-26

    (74 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    9TH WAVE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1