FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Microlife Digital Blood Pressure Monitor
K Number: K183469
·
Decision Mar 12, 2019
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
16
Review Days
88
Basic Information
- Device Name
- Microlife Digital Blood Pressure Monitor
- K Number
- K183469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microlife Intellectual Property GmbH
- Date Received
- December 14, 2018
- Decision Date
- March 12, 2019
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
G0 Blood Pressure Monitoring System (G0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
FDA 510(k)
FDA Class 2
·Cardiovascular
Globalcare Blood Pressure Monitor (GUS610)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Microlife Intellectual Property GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | Jun 28, 2023 | Substantially Equivalent |
| K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | May 19, 2023 | Substantially Equivalent |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) | Feb 3, 2023 | Substantially Equivalent |
| K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) | Mar 1, 2022 | Substantially Equivalent |
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Nov 4, 2021 | Substantially Equivalent |
| K202729 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Apr 8, 2021 | Substantially Equivalent |
| K200738 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Jul 23, 2020 | Substantially Equivalent |
| K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Jun 18, 2020 | Substantially Equivalent |
| K191829 | Microlife Non-Contact Infrared Forehead Thermometer | Feb 13, 2020 | Substantially Equivalent |
| K183663 | Microlife Digital Infrared Ear Thermometer | Jul 16, 2019 | Substantially Equivalent |