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

    DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR

    K Number: K981602 · Decision Jul 17, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    10
    Review Days
    73

    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
    DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR
    K Number
    K981602
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunrise Medical Hhg, Inc.
    Date Received
    May 5, 1998
    Decision Date
    July 17, 1998
    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 Sunrise Medical Hhg, Inc.

    K Number Device Name
    K083249 QUICKIE RHYTHM
    K012437 DEVILBISS SLEEP RECORDER MODEL # RM60
    K020329 DEVILBISS PD1000
    K020900 DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM
    K011229 DEVILBISS 9000 SERIES CPAP, MODEL 9001
    K003626 DEVILBISS HUMIDIFIER
    K993492 DEVILBISS NEBULIZER MODEL 800
    K991722 DEVILBISS 5 LITER OXYGEN CONCENTRATOR
    K982304 DEVILBISS SUCTION UNIT