Truly Instrument Limited
Kwai Chung, HK
TRULY INSTRUMENT LIMITED appears in FDA device records in Kwai Chung, HK. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Truly Instrument Limited between 2008 and 2023. The busiest year on record is 2009, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 3 |
| 2012 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220276 | Infrared Thermometer TET-351 | FLL | Substantially Equivalent | |
| K192023 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K170545 | Automatic Wrist Bluetooth Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K113083 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K113085 | TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K091434 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M | DXN | Substantially Equivalent | |
| K091415 | TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M | DXN | Substantially Equivalent | |
| K090564 | TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 | FLL | Substantially Equivalent | |
| K081852 | TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003657019 | 3003657019 | TRULY INSTRUMENT LIMITED | 2ND FLOOR, 1-3 WING YIP ST., KWAI CHUNG -- HK | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain