← Product Code [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH) · K953762 # HEART 400 ECG TRANSMITTER (K953762) _Aerotel, Ltd. · DXH · Jul 18, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K953762 ## Device Facts - **Applicant:** Aerotel, Ltd. - **Product Code:** [DXH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH.md) - **Decision Date:** Jul 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2920 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The device is not intended to be used for long-term monitoring or when the patient is not capable of actuating the device or the telephone. ## Device Story Battery-powered 3-lead ECG transmitter; captures patient ECG via electrodes and patient cable; transmits 3-channel ECG signal via telephone handset to central receiving station (e.g., Heartline 3000). Operated by patient; used for immediate transmission of ECG data. Device lacks internal memory; transmission occurs in real-time during signal acquisition. Receiving center staff edit and record ECG for clinical review. Facilitates remote cardiac assessment by physicians. ## Clinical Evidence Clinical testing involved three volunteers comparing ECG quality between Heart 400 and Heart 1001 via telephone lines. Results demonstrated equivalent signal quality in all cases. ## Technological Characteristics Battery-powered 3-lead ECG transmitter; FM transmission; analog circuitry; patient electrodes and cable interface. Bench tests performed: common mode rejection ratio, frequency response, audio signal sound level, temperature stress, electromagnetic immunity, shock, and vibration. ## 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 - Aerotel Heart 1001 ECG Transmitter ([K931020](/device/K931020.md)) ## Reference Devices - Aerotel Heartline 3000 ([K930314](/device/K930314.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} 201 438 3213 P.02 # K953762 JUL 18 1996 Aerotel Ltd. Heart 400 ECG Transmitter K953762 Request for Additional Information K953762 July 15, 1996 revised 510(k) Summary ## AEROTEL LTD. ### 510(k) Submission **Heart 400 ECG Transmitter (H400)** ### 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements Regulation par 807.92, effective March 14, 1995. 1. Submitter Name: Aerotel Ltd Address: 5 Hazoref St., Holon 58856, Israel Telephone Number: 972-3-5596111 Contact person: Dr. George Myers, 201-438-2310 Date prepared: July 13, 1995. 2. Device Proprietary name: Heart 400 Common Name: Electrocardiograph Telephonic Transmitter Classification Name: Transmitters and Receivers, electrocardiograph, telephone The Heart 400 is a battery-powered ECG transmitter that is capable of transmitting a 3-channel ECG signal by means of a telephone to a central receiving station. 3. Predicate Device Aerotel Heart 1001 ECG Transmitter, K931020 4. Description The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. {1} 201 438 3213 P.03 The Heart 400 transmits each of leads I, II, III as selected by the patient. Patient connection is done by means of electrodes and a patient cable. The electrodes are attached by the physician. To transmit the electrocardiogram, the telephone handset transmitter is placed over the device and the On/Off button of the H400 is released. At the receiving center, the ECG will be edited and recorded. ## 5. Intended Use The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The device is not intended to be used for long-term monitoring or when the patient is not capable of actuating the device or the telephone. ## 6. Comparison The Heart 400 has basically the same physical characteristics as the predicate device, except that the Heart 400 does not have a memory. Thus, when the Heart 400 is used, the electrocardiogram is transmitted on the telephone at the same time it is taken, while with the Heart 1001 there can be a time lag. Apart from that, both use FM transmission, similar circuitry, and similar patient electrodes. This difference is not critical to the use of the device, because the Heart 400 is used when the electrocardiogram is to be transmitted immediately. ### b. Performance Data #### (1) Non-clinical tests Non-clinical tests provided include bench tests of common mode rejection ratio, frequency response, sound level of the audio signal, temperature stress, electromagnetic immunity, and shock and vibration. There is no safety question, since the Heart 400 is battery operated. #### (2) Clinical Tests Electrocardiograms were taken from three volunteers using the Heart 400 and the Heart 1001, and transmitting the electrocardiograms over telephone lines. The quality of the electrocardiograms in every case is equivalent. #### (3) Conclusion {2} 1. 15, INC. 201 438 3213 P.04 The conclusion drawn from these tests is that the Heart 400 is equivalent in safety and efficacy to its predicate device --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K953762](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXH/K953762) **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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