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Found 6 results
510(k) Data Aggregation
K Number
K170423Device Name
DentureID Microchip
Manufacturer
CMP Industries LLC
Date Cleared
2017-10-25
(254 days)
Product Code
PYQ, LWH, NRV, OUG
Regulation Number
880.6300Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances.
Device Description
DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DentureID.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip. DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flange of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient.
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K Number
K983049Device Name
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
Manufacturer
AMERICAN ELECTROMEDICS CORP.
Date Cleared
1998-11-18
(78 days)
Product Code
ETY
Regulation Number
874.1090Why did this record match?
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Matched: '880.6300'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The American Electromedics Quik Tymp 1 (QT1) Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Device Description
The American Electromedics Quik Tymp 1 (QT1) Tympanometer/Audiometer With Integral Printer is an impedance tympanometer. The American Electromedics Quik Tymp 1 (QT1) Tympanometer with Integral Printer is an impedance tympanometer which has a built-in printer.
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K Number
K983051Device Name
AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
Manufacturer
AMERICAN ELECTROMEDICS CORP.
Date Cleared
1998-11-18
(78 days)
Product Code
ETY
Regulation Number
874.1090Why did this record match?
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Matched: '880.6300'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The American Electromedics Race Car Tympanometer/ Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Device Description
The American Electromedics Race Car Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.
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K Number
K983046Device Name
AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
Manufacturer
AMERICAN ELECTROMEDICS CORP.
Date Cleared
1998-11-17
(77 days)
Product Code
ETY
Regulation Number
874.1090Why did this record match?
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Matched: '880.6300'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Device Description
The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer.
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K Number
K983048Device Name
AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
Manufacturer
AMERICAN ELECTROMEDICS CORP.
Date Cleared
1998-11-17
(77 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
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Matched: '880.6300'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Device Description
The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.
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K Number
K960044Device Name
ULTRAMAX/MODEL NUMBER A1
Manufacturer
ENTLAB OY
Date Cleared
1996-08-02
(213 days)
Product Code
LWI
Regulation Number
892.1560Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultramax ultrasonic diagnostic system is intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity.
Device Description
The Ultramax is an A-scan, pulseecho device, equipped with a single unfocused flat 8 mm 3 MHz transducer. Pulse repetition rate is fixed at 300 Hz. The only controls on the device are the receiver gain, and the range that can be selected between "8" (0-8 cm), " 4 " (0-4 cm) and "4E" (4-8 cm). These selections do not effect the emitted acoustic power.
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