Smash Ent., Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Smash Ent., Inc. makes
Smash Ent., Inc. manufactures ionometers and their accessories for measuring electrolyte concentrations, syringe pumps for controlled fluid delivery, and enteral feeding bags for nutritional administration. The syringe pump (MS2000) is designed for precise medication or nutrient infusion, while the enteral feeding bags (ENTERA) are intended for tube feeding applications.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are authorised for commercial distribution in the United States, where the manufacturer is based.
Catalogue
Ionometer Ef And Accessories Ref K870183
Regimes: 510(k) Registry: 510(k)Syringe Pump MS2000 Ref K880857
Regimes: 510(k) Registry: 510(k)Entera* Enteral Feeding Bag Ref K881162
Regimes: 510(k) Registry: 510(k)Ionometer E-Hk And Accessories Ref K880373
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Smash Ent., Inc. have in the registry?
The registry currently lists 4 devices for Smash Ent., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smash Ent., Inc.'s devices?
Among its 4 most recently registered devices, Smash Ent., Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Smash Ent., Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Smash Ent., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smash Ent., Inc. in the registry?
The most recently registered devices listed for Smash Ent., Inc. include IONOMETER EF AND ACCESSORIES, SYRINGE PUMP MS2000, ENTERA* ENTERAL FEEDING BAG and IONOMETER E-HK AND ACCESSORIES.