Custom Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Custom Medical, Inc. makes
Custom Medical, Inc. manufactures color-tinted tubing for medical applications, single-use manual resuscitators, and custom intravenous (IV) sets designed for one-time use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. The company operates from the United States.
Catalogue
Red Color-Tinted Tubing Ref K832758
510(k) 510(k)Single Use Manual Resuscitators Ref K905002
510(k) 510(k)Custom Iv Set Ref K830182
510(k) 510(k)
Frequently asked questions
How many devices does Custom Medical, Inc. have in the registry?
The registry currently lists 3 devices for Custom Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Custom Medical, Inc.'s devices?
Among its 3 most recently registered devices, Custom Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Custom Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Custom Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Custom Medical, Inc. in the registry?
The most recently registered devices listed for Custom Medical, Inc. include RED COLOR-TINTED TUBING, SINGLE USE MANUAL RESUSCITATORS and CUSTOM IV SET.