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Found 5 results
510(k) Data Aggregation
K Number
K162589Device Name
Adscope 658 Electronic Stethoscope
Manufacturer
AMERICAN DIAGNOSTIC CORP.
Date Cleared
2017-03-10
(175 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Adscope® 658 Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds. Frequency selection and volume buttons enable operator control. The 658 can be used on patients of any age undergoing a physical assessment. This device is designed for use in a professional setting by a healthcare practitioner.
Device Description
The Adscope® 658 Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds. Frequency selection and volume buttons enable operator control.
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K Number
K093495Device Name
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
Manufacturer
AMERICAN DIAGNOSTIC CORP.
Date Cleared
2010-11-19
(374 days)
Product Code
HLJ
Regulation Number
886.1570Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.
Device Description
The ophthalmoscope kits described in this submission include a battery handle and attachments which serve the intended use below. The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
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K Number
K060321Device Name
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
Manufacturer
AMERICAN DIAGNOSTIC CORP.
Date Cleared
2006-05-15
(95 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADSCOPE 657BK Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung, and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
Device Description
Not Found
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K Number
K012304Device Name
ADC 656 ELECTRONIC STETHOSCOPE
Manufacturer
AMERICAN DIAGNOSTIC CORP.
Date Cleared
2001-11-01
(104 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For listening and amplification of sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to intensify the acoustical sounds of the device.
American Diagnostic Corporation's number 656 Electronic Stethoscope indications for use as an electronic stethoscope which will electronically amplfy sounds associated with the heart, arteries, veins and other internal organs. American Diagnostic intends to provide this device for use by healthcare providers and not for use by the general public.
Device Description
ADC #656BK Electronic Scope
Basic design is identical in both operation and functionality to the Graham-Field Healthcare Products, Labtron Electronmax (510(k) K961857). The main amplifying chestpiece is identical to the Graham-Field Healthcare Products stethoscope in design, function and performance. The headset assembly is identical to one used on numerous other ADC stethoscopes (510(k) 935544).
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K Number
K962655Device Name
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
Manufacturer
AMERICAN DIAGNOSTIC CORP.
Date Cleared
1997-01-27
(203 days)
Product Code
DXQ
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DIAGNOSTIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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