Rossmax International Ltd.
Taipei, TW
ROSSMAX INTERNATIONAL LTD. appears in FDA device records in Taipei, TW. FDA records list 16 510(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 16 510(k) clearances for Rossmax International Ltd. between 1998 and 2006. The busiest year on record is 1999, with 4. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 4 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 3 |
| 2005 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060342 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K | DXN | Substantially Equivalent | |
| K052727 | ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 | DXN | Substantially Equivalent | |
| K021225 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I | DXN | Substantially Equivalent | |
| K013583 | ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | |
| K013539 | ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | |
| K011539 | ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | |
| K011352 | ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS | DXN | Substantially Equivalent | |
| K011523 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 | DXN | Substantially Equivalent | |
| K993460 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 | DXN | Substantially Equivalent | |
| K993429 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 | DXN | Substantially Equivalent | |
| K993426 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44 | DXN | Substantially Equivalent | |
| K993542 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46 | DXN | Substantially Equivalent | |
| K993432 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 | DXN | Substantially Equivalent | |
| K992388 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 | DPW | Substantially Equivalent | |
| K992387 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 | DPW | Substantially Equivalent | |
| K964153 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000 | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680548 | 3003247551 | ROSSMAX INTERNATIONAL LTD. | 12F., NO.189, KANG CHIEN RD., TAIPEI 114 TW | 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