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FDA 510(k)

HEART 1001

K-Number: K931020 · 1995-01-11

ApplicantAerotel, Ltd.
Decision Date1995-01-11
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART 1001 is the device name listed in this FDA 510(k) record. The listed applicant is Aerotel, Ltd.. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K931020. 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 1001?

HEART 1001 is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Aerotel, Ltd.. The 510(k) number is K931020.

When did HEART 1001 receive FDA 510(k) clearance?

HEART 1001 received FDA 510(k) clearance on 1995-01-11, under 510(k) number K931020.

Who is the listed applicant for HEART 1001?

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 1001?

The FDA product code for HEART 1001 is DXH. This falls under the Hematology category.

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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 TRANSMITTERK953762HEART 400 ECG TRANSMITTERK961362AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACEK950004HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTERK930314HEARTLINE 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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