← Product Code [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH) · K965101 # CARDIOBEEPER CB-12L (K965101) _Meridian Medical Technologies, Inc. · DXH · Mar 17, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K965101 ## Device Facts - **Applicant:** Meridian Medical Technologies, Inc. - **Product Code:** [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH.md) - **Decision Date:** Mar 17, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2920 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## 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. ## Device Story Hand-held, battery-powered, single-channel transtelephonic ECG transmitter; inputs include ECG signals via two limb electrodes and a chest belt with thirteen silver/silver-chloride electrodes. Patient selects six chest electrodes (V1-V6) based on physician guidance. Device conditions ECG signal and transmits via telephone line using frequency modulation (FM) to remote medical receiving centers. Physician at receiving end reviews transmitted ECG to assess cardiac rhythm or 12-lead diagnostic data. Enables remote monitoring, reducing need for in-person clinic visits; facilitates timely clinical decision-making for cardiac patients. ## Clinical Evidence Clinical study of 97 patients compared diagnostic quality of CB-12L transmitted ECGs against standard 12-lead ECG systems. Results showed transmitted ECGs were comparable in diagnostic content. Study also confirmed patients could correctly apply electrodes and transmit quality tracings without direct medical supervision after training. ## Technological Characteristics Hand-held, battery-powered (9V alkaline). Electrodes: silver/silver-chloride. Frequency response: 0.05-150 Hz. CMRR: 80 dB min. Input dynamic range: ±2.3 mV. Transmission: FM, 1700 Hz carrier, 127.5 Hz/mV deviation sensitivity. System noise: <40 μV r.t.i. ## Regulatory 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. ## Predicate Devices - CardioBeeper® CB300 Memory Monitor ([K813101](/device/K813101.md)) - Card Guard 9000 ([K924486](/device/K924486.md)) - Aerotel Heartview ([K950004](/device/K950004.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} PY K965101 510(k) Summary CardioBeeper® CB-12L MAR 17 1997 1. Sponsor 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 Date Prepared: March 10, 1997 2. Device Name Classification Name: Telephone Electrocardiograph Transmitter Proprietary Name: CardioBeeper® CB-12L 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. 4. 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 CardioBeeper® CB-12L 510(k) 3/10/97 Page G-1 {1} mar 10,1997 05:00 COPY 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 | <40 μV r.t.i. | | Input Dynamic Range | ±2.3 mV | | Frequency Modulation | FM | | Carrier Frequency | 1700 ±20 Hz | | Deviation Sensitivity | 127.5 Hz/mV ±5% | | Battery | 9V alkaline | ## 5. Basis For Substantial Equivalence The CardioBeeper® CB-12L is substantially equivalent to other telephone electrocardiograph transmitters that have received 510(k) clearance for use by the patient in transmitting ECG information from a remote location to a physician's office, hospital, or other medical receiving center. Specifically, the rhythm strip operation of the CB-12L is substantially equivalent to the single-lead operation of the CardioBeeper® CB300 Memory Monitor (K813101), and the 12 lead operation of the CB-12L is substantially equivalent to the multiple-lead operation of the Card Guard 9000 (K924486) and the Aerotel Heartview (K950004). A clinical study was conducted with a study population of 97 patients in order to: (1) compare the diagnostic quality of 12 lead ECGs recorded using the CB-12L to those recorded using a standard 12 lead ECG system; and (2) compare the diagnostic quality of ECGs transmitted using the CB-12L with and without physician supervision. The results of the study showed that the ECGs transmitted using the CB-12L were comparable in diagnostic content to those recorded using a standard 12 lead machine. In addition, the results confirmed that the patients were capable of applying the electrodes and transmitting a quality 12 lead ECG tracing without direct medical supervision following appropriate training in the use of the CB-12L. CardioBeeper® CB-12L 510(k) 3/10/97 Page G-2 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K965101](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K965101) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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