FDA 510(k) · Microlife Intellectual Property
K040002: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1 (Microlife Intellectual Property Gmb)
Microlife Intellectual Property Gmb received FDA 510(k) K040002 for MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1, with a decision date of Mar 22, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K040002 |
|---|---|
| Pathway | 510(k) |
| Applicant | Microlife Intellectual Property Gmb |
| Device name | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1 |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | Jan 2, 2004 |
| Decision date | Mar 22, 2004 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
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. 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.
Later records that cite K040002
- K151330 Microlife Wrist Watch Blood Pressure Monitor (Microlife Intellectual Property, Jul 14, 2015, DXN)
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.