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FDA 510(k)

HEART 400 ECG TRANSMITTER

K-Number: K953762 · 1996-07-18

ApplicantAerotel, Ltd.
Decision Date1996-07-18
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART 400 ECG TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Aerotel, Ltd.. It received FDA 510(k) clearance on 1996-07-18 under 510(k) number K953762. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART 400 ECG TRANSMITTER?

HEART 400 ECG TRANSMITTER is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is Aerotel, Ltd.. The 510(k) number is K953762.

When did HEART 400 ECG TRANSMITTER receive FDA 510(k) clearance?

HEART 400 ECG TRANSMITTER received FDA 510(k) clearance on 1996-07-18, under 510(k) number K953762.

Who is the listed applicant for HEART 400 ECG TRANSMITTER?

The FDA 510(k) record lists Aerotel, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEART 400 ECG TRANSMITTER?

The FDA product code for HEART 400 ECG TRANSMITTER is DXH. This falls under the Hematology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Aerotel, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980144HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTERK961362AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACEK950004HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTERK931020HEART 1001K930314HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE

Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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