FDA device listing
Blood Pressure Monitor/ Model: LT-P30, LT-P30A, LT-P31, LT-P31A, LT-P35, LT-P50, LT-P51, LT-P70, LT-P71,Blood Pressure…
FDA device listing 1383635373 · Zhuhai Linte Medical Instrument Co., Ltd.
Key facts
| Proprietary names | Blood Pressure Monitor/ Model: LT-P30, LT-P30A, LT-P31, LT-P31A, LT-P35, LT-P50, LT-P51, LT-P70, LT-P71,Blood Pressure Monitor/ Model: PH-PMDBPAMP, Brand Name: Proheal,Upper Arm Blood Pressure Monitor/ Model: BU 420, Brand Name: Medisana |
|---|---|
| Owner/operator | Zhuhai Linte Medical Instrument Co., Ltd. |
| Owner/operator number | 10061578 |
| Premarket submissions | K220220 |
| Product codes | DXN |
| Device names | DXN - System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1130 |
| Review panels | Cardiovascular |
| Registered establishments | ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD. |
| Establishment registrations | 3016170326 |
| FEI numbers | 3016170326 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database