Pro-Tech, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Pro-Tech, Inc. makes
Pro-Tech, Inc. manufactures respiratory monitoring devices, including piezoelectric respiratory effort sensors like the Crystal Trace and EZ-1 System, as well as specialized sensors for sleep studies such as the Snoring Microphone (SM1) and Body Position Indicator (Model BPI1). Their portfolio also includes thermocouples designed for cannula applications and a PLM Sensor (Model PLM1) for periodic limb movement detection. Additionally, they produce interfaces like the Freedom Oximeter/EEG Digital Interface for multi-modal physiological data collection.
All listed devices fall under FDA Class II regulation and are cleared via the 510(k) pathway. The company is based in the United States, with its products registered in the FDA’s 510(k) database.
Catalogue
Crystal Trace Piezo Respiratory Effort Sensor Ref K923402
Regimes: 510(k) Registry: 510(k)Freedom Oximeter/Eeg Digital Interface Ref K924752
Regimes: 510(k) Registry: 510(k)Snoring Microphone, SM1 Ref K940015
Regimes: 510(k) Registry: 510(k)Body Position Indicator, Model BPI1 Ref K940013
Regimes: 510(k) Registry: 510(k)Cannula Style Thermocouples Ref K913396
Regimes: 510(k) Registry: 510(k)Ez-1 System Respiratory Effort Sensors Ref K913395
Regimes: 510(k) Registry: 510(k)Plm Sensor, Model PLM1 Ref K940014
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pro-Tech, Inc. have in the registry?
The registry currently lists 7 devices for Pro-Tech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pro-Tech, Inc.'s devices?
Among its 7 most recently registered devices, Pro-Tech, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Pro-Tech, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Pro-Tech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pro-Tech, Inc. in the registry?
The most recently registered devices listed for Pro-Tech, Inc. include CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR, FREEDOM OXIMETER/EEG DIGITAL INTERFACE, SNORING MICROPHONE, SM1 and BODY POSITION INDICATOR, MODEL BPI1.