# K965101: Cardiobeeper CB-12L

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Medical Technologies, Inc.
- Decided: Mar 17, 1997 after 87 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K813101 (1981). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813101: Cardiobeeper Memory Monitor, Survival Technology, Inc. (1981) Summary page 2.
- K924486: Card Guard, Model CG-9000, Card Guard Scientific Survival, Ltd. (1994) Summary page 2.
- K950004: Heartview (TM) 12-Lead Electrocardiograph Recorder/Transmitter, Aerotel, Ltd. (1995) Summary page 2.

## Most influential descendants
- K031229: Telzuit Cardiac Monitoring System (2003), 0 descendants of its own
- K983582: Cardiobeeper CB250 (1998), 0 descendants of its own
- K980144: Heartview P12/8 Electrocardiograph Recorder and Transmitter (1998), 0 descendants of its own

## Recalls of this device
- Oct 11, 2013 · Class II · Z-1011-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag

## Indications for use
The CardicBeeper® CB-12L is intended to condition an electrocardiograph signal so that it can be transmitted via a telephone line to a remote location. The CB-12L is designed to be used by a patient to transmit a rhythm strip or a 12 lead ECG signal in real time to a physician’s office, hospital or other medical receiving center. Note that due to the discrete options for selecting the precordial electrode positions, the CB-12L transmission may only approximate a standard 12 lcad ECG for some patients.

Source page: https://510kreport.com/device/K965101
Methodology: https://510kreport.com/methodology