FDA 510(k) · Rossmax International
K010498: WRISTWATCH BLOOD PRESSURE MONITOR A46 (Rossmax Internationl , Ltd.)
Rossmax Internationl , Ltd. received FDA 510(k) K010498 for WRISTWATCH BLOOD PRESSURE MONITOR A46, with a decision date of Mar 20, 2001 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K010498 |
|---|---|
| Pathway | 510(k) |
| Applicant | Rossmax Internationl , Ltd. |
| Device name | WRISTWATCH BLOOD PRESSURE MONITOR A46 |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | Feb 21, 2001 |
| Decision date | Mar 20, 2001 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record because FDA's summary PDF was not available at the usual address. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Cuff. These are heuristics, not FDA fields.