(87 days)
Not Found
No
The description focuses on signal conditioning and transmission, with no mention of AI/ML terms or functions like analysis, interpretation, or prediction.
No
The device is described as an ECG transmitter used to send signals to a medical center, not to provide therapy.
Yes
The device is described as capturing (via electrodes) and transmitting ECG signals for a physician's office, hospital, or other medical receiving center, and the study evaluated the "diagnostic quality" of the ECGs. This indicates its use in aiding diagnosis rather than just therapy or general health monitoring.
No
The device description explicitly details hardware components including a transmitter/electronics module, limb electrodes, and a chest belt with electrodes.
Based on the provided information, the CardioBeeper® CB-12L is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- CardioBeeper® CB-12L Function: The CardioBeeper® CB-12L conditions and transmits an electrocardiograph (ECG) signal. An ECG is a recording of the electrical activity of the heart, which is a physiological signal measured from the living body. It does not involve testing samples taken from the body.
The device is clearly described as a system for acquiring and transmitting a physiological signal (ECG) from a patient to a remote location for interpretation. This falls under the category of a diagnostic device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CardioBeeper® 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 lead ECG for some patients.
Product codes
Not Found
Device Description
The CardioBeeper® CB-12L is a compact, hand-held, battery-powered, single channel transtelephonic ECG transmitter that is capable of transmitting a 24 second rhythm strip or a 45 second 12 lead ECG. The CB-12L consists of a transmitter/ electronics module (TEM), two limb electrodes (RA and LL) attached to the TEM via separate cables, and a chest belt containing the third limb electrode (LA) and thirteen silver silver-chloride electrodes. Prior to a patient using the CB-12L, the patient's physician must select the six most appropriate chest belt electrodes to function as the precordial V1-V6 electrodes according to the patient's chest size. Technical specifications for the CB-12L are as follows:
| Low End Frequency Response | 0.05 Hz |
|---|---|
| High End Frequency Response | 150 Hz min. |
| Common Mode Rejection Ratio | 80 dB min. |
| System Noise |
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
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510(k) Summary
CardioBeeper® CB-12L
MAR 1 7 1997
Sponsor 1.
Meridian Medical Technology 10240 Old Columbia Road Columbia, MD 21046 TEL: (410) 309-6830 FAX: (410) 309-1475
Contact Persons: Herb Reinhold, Senior Vice President Bruce Ward, Vice President of Research and Development
March 10, 1997 Date Prepared:
2. Device Name
Classification Name: Telephone Electrocardiograph Transmitter
CardioBeeper® CB-12L Proprietary Name:
3. Intended Use
The CardioBeeper® 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 lead ECG for some patients.
Device Description 4.
The CardioBeeper® CB-12L is a compact, hand-held, battery-powered, single channel transtelephonic ECG transmitter that is capable of transmitting a 24 second
CardioBeeper® CB-12L 510(k) 3/10/97
1
JURY
rhythm strip or a 45 second 12 lead ECG. The CB-12L consists of a transmitter/ electronics module (TEM), two limb electrodes (RA and LL) attached to the TEM via separate cables, and a chest belt containing the third limb electrode (LA) and thirteen silver silver-chloride electrodes. Prior to a patient using the CB-12L, the patient's physician must select the six most appropriate chest belt electrodes to function as the precordial V1-V6 electrodes according to the patient's chest size. Technical specifications for the CB-12L are as follows:
| Low End Frequency Response | 0.05 Hz |
|---|---|
| High End Frequency Response | 150 Hz min. |
| Common Mode Rejection Ratio | 80 dB min. |
| System Noise |