Simplex Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Simplex Medical Systems, Inc. makes
Simplex Medical Systems, Inc. manufactures neonatal breathing circuit modifications and systems, including the Simplex Neonatal Breathing Circuit System and the Simplex Airbrator. These products are designed for use in neonatal respiratory support, providing controlled airflow and ventilation for infants.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
Neonatal Breathing Circuit Modification Ref K932288
Regimes: 510(k) Registry: 510(k)Simplex Neonatal Breathing Circuit System Ref K904396
Regimes: 510(k) Registry: 510(k)Simplex Airbrator Ref K970249
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Simplex Medical Systems, Inc. have in the registry?
The registry currently lists 3 devices for Simplex Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Simplex Medical Systems, Inc.'s devices?
Among its 3 most recently registered devices, Simplex Medical Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Simplex Medical Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Simplex Medical Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Simplex Medical Systems, Inc. in the registry?
The most recently registered devices listed for Simplex Medical Systems, Inc. include NEONATAL BREATHING CIRCUIT MODIFICATION, SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM and SIMPLEX AIRBRATOR.