Medtel Pty., Ltd.
Country not established
- Devices
- 8
What Medtel Pty., Ltd. makes
Medtel Pty., Ltd. manufactures a range of medical monitors for surgical and critical care environments, including portable operating room monitors (e.g., HS10, HS20, HS30/40), central monitoring systems (e.g., D668, D664, CM10), and physiological monitors for adult patients (e.g., HSH/H512). Their product line also includes dedicated critical care monitors (e.g., H59) and series-specific monitors (HS17/HS18). These devices are designed for real-time patient vital sign tracking in operating rooms, intensive care units, and central monitoring stations.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via the 510(k) pathway. Their products are listed in the FDA’s 510(k) registry. Medtel Pty., Ltd. is based in the United States.
Catalogue
HS20 Port. Operating Room Monitor Ref K820399
Regimes: 510(k) Registry: 510(k)HS17/HS18 Series Monitors Ref K820670
Regimes: 510(k) Registry: 510(k)Portable Operat. Rm. Monitors HS30/40 Ref K832356
Regimes: 510(k) Registry: 510(k)D668 & D664 Central Monitoring Systems Ref K800243
Regimes: 510(k) Registry: 510(k)Hsh/H512 Adult Physiological Monitors Ref K791838
Regimes: 510(k) Registry: 510(k)HS10 Portable Operating Room Monitor Ref K802184
Regimes: 510(k) Registry: 510(k)H59 Critical Care Monitor Ref K791839
Regimes: 510(k) Registry: 510(k)CM10 Central Monitoring System Ref K820671
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtel Pty., Ltd. have in the registry?
The registry currently lists 8 devices for Medtel Pty., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtel Pty., Ltd.'s devices?
Among its 8 most recently registered devices, Medtel Pty., Ltd. has devices listed in FDA 510(k) (8 devices).
What risk classes do Medtel Pty., Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Medtel Pty., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtel Pty., Ltd. in the registry?
The most recently registered devices listed for Medtel Pty., Ltd. include HS20 PORT. OPERATING ROOM MONITOR, HS17/HS18 SERIES MONITORS, PORTABLE OPERAT. RM. MONITORS HS30/40 and D668 & D664 CENTRAL MONITORING SYSTEMS.