Harvard Medical Devices, Ltd.
Tsimshatsui, Kowloon, HK
Harvard Medical Devices , Ltd. appears in FDA device records in Tsimshatsui, Kowloon, HK. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Harvard Medical Devices, Ltd. between 2008 and 2010. The busiest year on record is 2008, with 2. The most recent is 2010, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100620 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 | DXN | Substantially Equivalent | |
| K092558 | WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES | DXN | Substantially Equivalent | |
| K092557 | DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES | FLL | Substantially Equivalent | |
| K081159 | HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES | DXN | Substantially Equivalent | |
| K081061 | HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES | FLL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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