Introspect, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Introspect, Inc. makes
Introspect, Inc. manufactures otoscopes, including analog and digital video models designed for examining the ear canal and tympanic membrane. These devices support clinical diagnostics in medical settings by providing visual inspection capabilities.
The company’s otoscopes fall under FDA Class I medical devices and are listed via the 510(k) pathway. The portfolio is regulated under US FDA standards, and the manufacturer is based in the United States.
Catalogue
Imedge Video Ostoscope (Analog) Ref K951255
Regimes: 510(k) Registry: 510(k)Imedge Digita Otoscope Or Digital Video Otoscope Ref K950983
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Introspect, Inc. have in the registry?
The registry currently lists 2 devices for Introspect, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Introspect, Inc.'s devices?
Among its 2 most recently registered devices, Introspect, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Introspect, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Introspect, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Introspect, Inc. in the registry?
The most recently registered devices listed for Introspect, Inc. include IMEDGE VIDEO OSTOSCOPE (ANALOG) and IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE.