# K980144: Heartview P12/8 Electrocardiograph Recorder and Transmitter

- Pathway: 510(k) (Traditional)
- Applicant: Aerotel, Ltd.
- Decided: Jun 16, 1998 after 152 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K813101 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950004: Heartview (TM) 12-Lead Electrocardiograph Recorder/Transmitter, Aerotel, Ltd. (1995) Summary page 1.
- K965101: Cardiobeeper CB-12L, Meridian Medical Technologies, Inc. (1997) Summary page 1.
- K931020: HEART 1001, Aerotel, Ltd. (1995) Summary page 1.

## Indications for use
The HeartView P12/8 is a 12/8-lead Transtelephonic electrocardiographic recorder and transmitter which is intended to be used to record and transmit a patient's electrocardiogram (ECG) via the telephone to a diagnostic/emergency center. The HeartView P 12/8 can record either an eight lead or a twelve lead electrocardiogram, and has been designed so that the patient can attach the electrodes him/herself.

Source page: https://510kreport.com/device/K980144
Methodology: https://510kreport.com/methodology