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510(k) Data Aggregation

    K Number
    K230502
    Device Name
    Ear Pressure Relief Device(Model:ER813B)
    Date Cleared
    2023-06-09

    (105 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Al**bert **Novosino Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ear Pressure Relief Device is indicated for the treative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing loss. The Ear Pressure Reliever provides a method of ventilating the middle ear by momentarily increasing the air pressure in the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
    Device Description
    The Ear Pressure Relief Device is designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes. For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Ear Pressure Relief Device is activated by pressing and holding the adjustment button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear. Ear Pressure Relief Device is provided non-sterile, and is designed for reuse with a single patient.
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    K Number
    K173044
    Device Name
    Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
    Date Cleared
    2017-11-20

    (53 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Al**bert **Novosino Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REUSABLE BLOOD PRESSURE CUFF is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in infant, pediatric and adult sizes. The DISPOSABLE BLOOD PRESSURE CUFF is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes.
    Device Description
    The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics &PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 26 models with different size for different population with different arm size, and the 13 models of 26 are use single tube of air hose and other 13 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient. The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
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    K Number
    K131026
    Device Name
    BOSCH BLOOD PRESSURE METER (BP5000 BT)
    Date Cleared
    2013-11-14

    (216 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    RO**BERT **BOSCH HEALTHCARE SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bosch Blood Pressure Monitor (BP5000 BT) is intended for use by adults to measure systolic and diastolic pressures, as well as pulse rate, by the oscillometric method, with a telehealth system or for home use.
    Device Description
    The Bosch Blood Pressure Monitor (BP5000 BT) is an upper arm, non-invasive, blood pressure device, designed for home use. It is a simple device designed to measure a patient's systolic and diastolic pressures, as well as pulse rate using the oscillometric measuring method. The Bosch Blood Pressure Monitor (BP5000 BT) has a voice prompt function and a memory function. There are five available languages to choose from (US English, UK English. Spanish. French and German). The BP5000 BT can store up to 42 measurements, including their date and time stamp, in its memory. By pressing the memory button on the device, the last blood pressure measurement and pulse rate is displayed on the LCD screen and announced by the voice prompt. The volume can be adjusted by pressing the volume button. The Bosch Blood Pressure Monitor (BP5000 BT) is also designed to connect wirelessly, via Bluetooth, to a Bosch or Continua compliant telehealth patient interface. The connection is made automatically when the telehealth device prompts the patient to take their blood pressure measurement. Once the measurement is complete, the Bluetooth symbol on the blood pressure monitor will flash, indicating that the measurement is being transferred to the telehealth device. If Bluetooth is disabled, the BP5000 BT will store the measurements in its merhorv and will transmit all the stored data to the telehealth device once Bluetooth has been enabled.
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    K Number
    K093833
    Device Name
    KAPSS SPINAL SYSTEM
    Manufacturer
    Date Cleared
    2010-10-15

    (305 days)

    Product Code
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    RO**BERT **REID INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion. The system is also intended for posterior, non-pedicle fixation for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture. dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
    Device Description
    The KAPSS® Spinal System consists of longitudinal members (rods), anchors (screws and hooks), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.
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    K Number
    K092427
    Device Name
    SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
    Date Cleared
    2010-03-16

    (221 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AL**BERT **DAVYDOV DDS PC PROFESSIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spinal Guides PACS is intended to perform: operations relating to the acceptance of spinal X-ray medical images and patient demographic information, their display, digital processing, review and editing, measurements report generation with respective storage and teleradiology exchange capabilities. They are intended to be used by a physician to view the images and use as an aid in calculation of alteration of motion segment integrity (AOMSI) of human spine. This device is not intended to be used for mammography images and does not require usage of 5 Mega pixel monitors.
    Device Description
    The device is represented by a software computer program installed on regular computers. The device has two types of users: a web and a local user. The web user submits an image set for processing to the local user via internet to the device's database. The local user is viewing the images of the image set, process the image set and sends a PDF report with calculations for the web user.
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    K Number
    K093089
    Device Name
    MAGNUM NAIL
    Manufacturer
    Date Cleared
    2009-11-13

    (43 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    RO**BERT **REID INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Magnum Nail is intended for use in fixation of stable and unstable fractures of the proximal femur. The types of proximal femoral fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.
    Device Description
    The Magnum Nail consists of nails, distal bone screws, cannulated lag screws, cannulated blades and set screws in a variety of sizes to accommodate differing anatomic requirements.
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    K Number
    K072084
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Date Cleared
    2008-05-08

    (283 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIBO HONGYE SHANGQIN PLASTIC RUB**BERT **CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powdered vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
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    K Number
    K072085
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Date Cleared
    2007-09-04

    (36 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIBO HONGYE SHANGQIN PLASTIC RUB**BERT **CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed
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    K Number
    K063285
    Device Name
    RELIANCE CI PROCESS INDICATOR
    Manufacturer
    Date Cleared
    2007-01-12

    (73 days)

    Product Code
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AL**BERT **BROWNE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reliance™ CI Process Indicator is intended for routine monitoring of the Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance™ CI Process Indicator is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.
    Device Description
    The Reliance CI is a single-use chemical indicator with indicator ink printed on one end that was developed to monitor the peracetic acid (PAA) dose at the point of use in a Reliance™ EPS Endoscope Processing System employing Reliance™ DG Dry Germicide. The Reliance CI shows an incomplete color change when exposed to peracetic acid at a dose of 9,000 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle. The Reliance CI changes color from orange to white (colorless) when exposed to peracetic acid at a dose of 11,500 mg/L PAA min. in a Reliance™ EPS Endoscope Processing System cycle.
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    K Number
    K061737
    Device Name
    LOSS OF RESISTANCE SYRINGE
    Date Cleared
    2006-12-18

    (181 days)

    Product Code
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    RO**BERT **BUSSE & CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Busse Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
    Device Description
    The Busse Loss of Resistance Syringe is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip tip.
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