FDA 510(k) · Microlife Intellectual Property
K101275: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). (Microlife Intellectual Property GmbH)
Microlife Intellectual Property GmbH received FDA 510(k) K101275 for MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS)., with a decision date of May 28, 2010 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K101275 |
|---|---|
| Pathway | 510(k) |
| Applicant | Microlife Intellectual Property GmbH |
| Device name | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | May 6, 2010 |
| Decision date | May 28, 2010 |
| 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
510(k) Number (if known): ____________ Device Name: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) Indications For Use: The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office AFIB (TWIN200 AFS) is a device intended to measure the systolic and diastolic blood pressure, pulse rate, pulse pressure (PP) and mean arterial pressure (MAP) of an adult individual by using a non-invasive oscillometric technique in one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The device detects the appearance of.atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected. Prescription Use _X AND/OR Over-The-Counter Use ____ (Part 21 CFR 801 Subpart D)- (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Nme
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary 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 AFib / irregular rhythm, sensor Cuff. These are heuristics, not FDA fields.