Amzetta Technologies Private Limited
IndiaFDA applicant, unverified
- Devices
- 1
What Amzetta Technologies Private Limited makes
Amzetta Technologies Private Limited manufactures a modular patient monitoring system called B.O.L.T, which includes a base unit paired with disposable or reusable probes for non-invasive blood pressure measurement, infrared thermometry, pulse oximetry, and blood glucose, cholesterol, and hemoglobin testing. The system integrates these functions into a single platform for clinical use.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting their authorised status in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amzetta Technologies Private Limited have in the registry?
The registry currently lists 1 device for Amzetta Technologies Private Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amzetta Technologies Private Limited's devices?
Among its 1 most recently registered device, Amzetta Technologies Private Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Amzetta Technologies Private Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Amzetta Technologies Private Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amzetta Technologies Private Limited in the registry?
The most recently registered devices listed for Amzetta Technologies Private Limited include B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter.