WISC MED, LLC

Address:8383 Greenway Blvd,Middleton,WI,53562,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Speculum, Ent (EPY) (2) Otoscope (ERA) (1)

Premarket Exempt

Yes

Clear

WiscMed - 00850009819000 Catalog Number :

Device Description : The Wispr is general purpose handheld digital otoscope that provides a detailed The Wispr is general purpose handheld digital otoscope that provides a detailed view of the external auditory canal and tympanic membrane. The Wispr utilizes a nano camera (shrouded by a single-use speculum), LED fiber optic illumination, and a display screen that allows the user to view, evaluate and save images and video for further review. The primary user interface is a touch screen display and single push button. A USB port is provided that allows for off-line download of image and video files. The Wispr is designed to attach to current industry standard otoscope power handles.

Device Class : 1

Duns Number: 070666290

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

WiscMed - 00850009819017 Catalog Number :

Device Description : A single use, plastic, rigid, cone shaped, speculum designed specifically for us A single use, plastic, rigid, cone shaped, speculum designed specifically for use with the WiscMed Wispr digital otoscope. This item number consists of a quantity of 300 specula, packaged in plastic sleeves designed to fit traditional wall mounted specula holders found in most patient exam rooms.

Device Class : 1

Duns Number: 070666290

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

WiscMed - 00850009819024 Catalog Number :

Device Description : A single use, plastic, rigid, cone shaped, speculum designed specifically for us A single use, plastic, rigid, cone shaped, speculum designed specifically for use with the WiscMed Wispr digital otoscope. This item number consists of a quantity of 96 specula, packaged in plastic sleeves designed to fit traditional wall mounted specula holders found in most patient exam rooms.

Device Class : 1

Duns Number: 070666290

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

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