Egnell, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Egnell, Inc. makes
Egnell, Inc. manufactures neonatal resuscitation and support devices, including battery-operated breast pumps, neonatal resuscitation units, and suction pumps for gastric and universal use. Their portfolio also includes electronic infusion pumps for controlled fluid delivery and phototherapy lamps designed for newborns. The company produces compact, portable medical devices for critical care and pediatric applications.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight. No additional registries or international listings are specified.
Catalogue
Ameda Neonatal Resuscitation Unit- Ref K832637
Regimes: 510(k) Registry: 510(k)Ametherm Ref K840526
Regimes: 510(k) Registry: 510(k)Egnell-Lact B Battery-Operated Breast Pump Ref K844307
Regimes: 510(k) Registry: 510(k)Egnell Compact, Type Ehv Ref K812020
Regimes: 510(k) Registry: 510(k)Egnell Universal Suction Pump Ref K853909
Regimes: 510(k) Registry: 510(k)Pe-01 Electronic Infusion Pump Ref K812898
Regimes: 510(k) Registry: 510(k)Gastric Juices Suction Pump Ref K813095
Regimes: 510(k) Registry: 510(k)Universal Suction Pump Type Eus Ref K813312
Regimes: 510(k) Registry: 510(k)Ameda Phototherapy Lamp For Newborn Ref K834335
Regimes: 510(k) Registry: 510(k)Egnell Compact Suction Pump Ref K853917
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Egnell, Inc. have in the registry?
The registry currently lists 10 devices for Egnell, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Egnell, Inc.'s devices?
Among its 10 most recently registered devices, Egnell, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Egnell, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Egnell, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Egnell, Inc. in the registry?
The most recently registered devices listed for Egnell, Inc. include AMEDA NEONATAL RESUSCITATION UNIT-, AMETHERM, EGNELL-LACT B BATTERY-OPERATED BREAST PUMP and EGNELL COMPACT, TYPE EHV.