Gempco, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Gempco, Inc. makes
Gempco, Inc. manufactures medical equipment for neonatal care, including mobile newborn beds, bassinets, and integrated newborn bed and equipment cabinet units designed for hospital use. The company also produces special procedure bassinet units for controlled clinical environments.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Model Wc-102 Newborn Bed & Equipment Cabinet Ref K884280
Regimes: 510(k) Registry: 510(k)Model Wc-115 Mobile Bassinet Ref K884285
Regimes: 510(k) Registry: 510(k)Model Wc-107 Mobile Newborn Bed Ref K884283
Regimes: 510(k) Registry: 510(k)Special Procedures Base Unit Model 500 Ref K881713
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gempco, Inc. have in the registry?
The registry currently lists 4 devices for Gempco, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gempco, Inc.'s devices?
Among its 4 most recently registered devices, Gempco, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Gempco, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Gempco, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gempco, Inc. in the registry?
The most recently registered devices listed for Gempco, Inc. include MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET, MODEL WC-115 MOBILE BASSINET, MODEL WC-107 MOBILE NEWBORN BED and SPECIAL PROCEDURES BASE UNIT MODEL 500.