| Details of Equipment: |
 |
| Product Type: |
Insulin Pump |
| Brand Name: |
Medtronic MiniMed |
| Model Number: |
M994838A001 |
| NCA Equipment No.: |
7E5-7M-X3A-RDR |
| Product Name: |
M994838A001 |
| Intended Use: |
Delivery of insulin and also the pumps are intended to receive, display, and store sensor glucose values received
from compatible transmitting devices (Bluetooth Low Energy, v4.2). |
| Additional Details for Radio Equipment: |
| Frequency Range: |
2400-2483.5 MHz |
| RF Output Power Radiation: |
-2.17 dBm |
| RF Output Power Conducted: |
|
| RF Channel Spacing: |
<2 MHz |
| RF Output Impedance: |
|
| Type Of Modulation: |
GFSK |
| Bandwidth: |
|
| Software Version: |
|
| Antenna Type: |
Ceramic Chip Integral Antenna |
| Antenna Gain: |
< 0.5 dBi |
| Technical Variants: |
|
| Details of Certificate of Compliance: |
| Issuing Body: |
Medtronic MiniMed, Inc. - EU Declaration of Conformity |
| Issuing Date: |
01/15/2021 |
| Validity: |
Unlimited |
| Standards: |
| EMC: |
EN 301 489-1 v2.2.0; EN 301 489-17 v3.2.0 |
| Radio: |
EN 300 328 v2.1.1 |
| Health And Safety: |
EN 60601-1:2006 + A1:2013 + A12:2014; EN 62479:2010 |
| Manufacture's Information: |
| Name Of Manufacturer: |
Medtronic MiniMed, Inc. |
| Address Of Manufacturer: |
18000 Devonshire Street, Northridge, 91325, CA, USA |