# K061161: Blood Pressure Meter, Model CH-311B

- Pathway: 510(k) (Special)
- Applicant: Citizen Watch Co., Ltd.
- Decided: Jun 26, 2006 after 61 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Model CH-GI1 B Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physidan.

Source page: https://510kreport.com/device/K061161
Methodology: https://510kreport.com/methodology