BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MEDI PUMP ASPIRATOR MODELS 1130 AND 1135

    K Number: K952806 · Decision Oct 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    9
    Review Days
    129

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MEDI PUMP ASPIRATOR MODELS 1130 AND 1135
    K Number
    K952806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thomas Industries
    Date Received
    June 19, 1995
    Decision Date
    October 26, 1995
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BTA), ordered by most recent decision date.

    Momcozy Nasal Aspirator (BN007)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Suction Pump (SU-90)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Thomas Industries

    K Number Device Name
    K041199 MEDI-PUMP ASPIRATOR, MODEL 1615
    K965059 CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
    K950290 MEDI - PUMP
    K951729 MEDI - PUMP
    K950867 MEDI - PUMP
    K944399 MEDI-PUMP
    K925010 NEBULIZER PUMP, POWERED, MODEL 1110
    K925011 NEBULIZER PUMP, POWERED MODEL 1180