# K092576: Gem Heart One/One+

- Pathway: 510(k) (Traditional)
- Applicant: Gem-Med S.L.
- Decided: Sep 4, 2009 after 14 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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. The FDA summary names its predicate without a number.
- (no number) Cardioline AR 1200: named in the summary without a submission number
- (no number) CorScreen: named in the summary without a submission number

## Indications for use
Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register, analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width. It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the records and send them to a PC by serial communication (RS-232, USB and LAN). The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program. For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient. It is intended for use in routine ECG recording by trained physicians in hospital environment. * The Gem Heart One/One+ is a standard portable electrocardiograph that measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements. * Intended use is equivalent to the intended use of the predicate Cardioline AR 1200 and CorScreen electrocardiograph.

Source page: https://510kreport.com/device/K092576
Methodology: https://510kreport.com/methodology