Goldway US, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Goldway US, Inc. makes
Goldway US, Inc. manufactures digital colposcope imaging systems, such as the SLC-2000 model, for cervical cancer screening and diagnostic imaging. The company also produces multi-parameter patient monitors, including the UT4000A and UT4000F models, designed to track vital signs like heart rate, blood pressure, and oxygen saturation. Additional offerings include the Comen multi-parameter patient monitor, intended for continuous patient monitoring in clinical settings.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Goldway UT4000A Vital Signs Monitor Ref K033988
Regimes: 510(k) Registry: 510(k)Comen Multi-Parameter Patient Monitor Ref K112877
Regimes: 510(k) Registry: 510(k)Goldway Patient Monitor, Model # UT4000F Ref K021154
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Goldway Us, Inc. have in the registry?
The registry currently lists 4 devices for Goldway Us, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Goldway Us, Inc.'s devices?
Among its 4 most recently registered devices, Goldway Us, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Goldway Us, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Goldway Us, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Goldway Us, Inc. in the registry?
The most recently registered devices listed for Goldway Us, Inc. include GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000, GOLDWAY UT4000A VITAL SIGNS MONITOR, COMEN MULTI-PARAMETER PATIENT MONITOR and GOLDWAY PATIENT MONITOR, MODEL # UT4000F.