Isothermal Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Isothermal Systems, Inc. makes
Isothermal Systems, Inc. makes the SERVO-PAK MOLEL 0030 and the Neonatal Breathing Circuit System.
These devices are classified as Class I and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Servo-Pak Molel 0030 Ref K771510
Regimes: 510(k) Registry: 510(k)Neonatal Breathing Circuit System Ref K801087
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isothermal Systems, Inc. have in the registry?
The registry currently lists 2 devices for Isothermal Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isothermal Systems, Inc.'s devices?
Among its 2 most recently registered devices, Isothermal Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Isothermal Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Isothermal Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Isothermal Systems, Inc. in the registry?
The most recently registered devices listed for Isothermal Systems, Inc. include SERVO-PAK MOLEL 0030 and NEONATAL BREATHING CIRCUIT SYSTEM.