The following data is part of a premarket notification filed by Amzetta Technologies Private Limited with the FDA for 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.
| Device ID | K182401 |
| 510k 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 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | AmZetta Technologies Private Limited Kumaran Nagar, Semmanchery, Off Rajiv Gandhi Salai (OMR) Chennai, IN 600 119 |
| Contact | Sridharan Mani |
| Correspondent | Sridharan Mani AmZetta Technologies Private Limited Kumaran Nagar, Semmanchery, Off Rajiv Gandhi Salai (OMR) Chennai, IN 600 119 |
| Product Code | MWI |
| Subsequent Product Code | CHH |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | GKR |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-08-28 |