Creative Biomedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Creative Biomedics, Inc. makes
Creative Biomedics, Inc. manufactures portable pulmonary function testing devices, including the DX1, DX1 Portable Lite, and DX1 Portable Plus, as well as disposable pulmonary function filters. These products are designed for measuring lung function in clinical and home settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
DX1 Ref K951227
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Disposable Pulmonary Function Filter Ref K951410
Regimes: 510(k) Registry: 510(k)DX1-Portable Ref K951157
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Creative Biomedics, Inc. have in the registry?
The registry currently lists 4 devices for Creative Biomedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Creative Biomedics, Inc.'s devices?
Among its 4 most recently registered devices, Creative Biomedics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Creative Biomedics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Creative Biomedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Creative Biomedics, Inc. in the registry?
The most recently registered devices listed for Creative Biomedics, Inc. include DX1, THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS, DISPOSABLE PULMONARY FUNCTION FILTER and DX1-PORTABLE.