Amzetta Technologies Private Limited · Class II · Cleared Aug 28, 2019
| K-number | K182401 |
| Device name | 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 |
| Applicant | Amzetta Technologies Private Limited |
| Product code | MWI |
| Device class | Class II |
| Decision date | Aug 28, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 870.2300 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov