Automatic Upper Arm Blood Pressure Monitor
FDA 510(k) clearance K193627 · decided 2020-07-12
Clearance details
- K-number
- K193627
- Device name
- Automatic Upper Arm Blood Pressure Monitor
- Applicant
- Dongguan E-Test Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-26
- Decision date
- 2020-07-12
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dongguan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 recall (Z-0032-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2024-10-08 |
| MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. recall (Z-0033-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2024-10-08 |
| MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. recall (Z-0034-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2024-10-08 |
| Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS recall (Z-1459-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-04-01 |