Sontek Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Sontek Industries, Inc. makes
Sontek Industries, Inc. manufactures airway management and patient safety devices, including tracheal tube connectors like the BODIA TRACH-SAF DOUBLE SWIVEL and BODIA BRONCH-SAF DOUBLE SWIVEL, oral airway devices such as the TUBE-TITLE and BITE-BLOCK, and communication aids like the BODAI PATIENT COMMUNICATOR. Their portfolio also includes suction devices, such as the BODAI SUCTION-SAFE 4, and specialized connectors like the BODAI SWIVEL Y.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. Sontek Industries, Inc. is based in the United States.
Catalogue
Bodia Trach-Saf Double Swivel Ref K833372
Regimes: 510(k) Registry: 510(k)Tube-Title Ref K833361
Regimes: 510(k) Registry: 510(k)Bite-Block Ref K833374
Regimes: 510(k) Registry: 510(k)Bodai Patient Communicator Ref K812720
Regimes: 510(k) Registry: 510(k)Bodai Suction -Safe 4 Ref K811241
Regimes: 510(k) Registry: 510(k)Bodai Swivel Y Ref K813324
Regimes: 510(k) Registry: 510(k)Bodia Bronch-Saf Double Swivel Ref K833373
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sontek Industries, Inc. have in the registry?
The registry currently lists 7 devices for Sontek Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sontek Industries, Inc.'s devices?
Among its 7 most recently registered devices, Sontek Industries, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Sontek Industries, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Sontek Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sontek Industries, Inc. in the registry?
The most recently registered devices listed for Sontek Industries, Inc. include BODIA TRACH-SAF DOUBLE SWIVEL, TUBE-TITLE, BITE-BLOCK and BODAI PATIENT COMMUNICATOR.