Hal-Hen Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Hal-Hen Co., Inc. makes
Hal-Hen Co., Inc. manufactures the PENTAX ST-1A, a medical endoscope used for diagnostic and therapeutic procedures, and the NUVOX Bedside Tinnitus Masker, a device designed to reduce tinnitus symptoms for patients.
The company’s products are regulated as Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Pentax St-1A Ref K780738
Regimes: 510(k) Registry: 510(k)Nuvox Bedside Tinnitus Masker Ref K802750
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hal-Hen Co., Inc. have in the registry?
The registry currently lists 2 devices for Hal-Hen Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hal-Hen Co., Inc.'s devices?
Among its 2 most recently registered devices, Hal-Hen Co., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hal-Hen Co., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hal-Hen Co., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hal-Hen Co., Inc. in the registry?
The most recently registered devices listed for Hal-Hen Co., Inc. include PENTAX ST-1A and NUVOX BEDSIDE TINNITUS MASKER.