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FDA 510(k)

CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)

K-Number: K942586 · 1995-05-10

ApplicantTelescan Medical Systems
Decision Date1995-05-10
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) is the device name listed in this FDA 510(k) record. The listed applicant is Telescan Medical Systems. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K942586. 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 CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)?

CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Telescan Medical Systems. The 510(k) number is K942586.

When did CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) receive FDA 510(k) clearance?

CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) received FDA 510(k) clearance on 1995-05-10, under 510(k) number K942586.

Who is the listed applicant for CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)?

The FDA 510(k) record lists Telescan Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)?

The FDA product code for CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) is DXH. This falls under the Hematology category.

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Other records listing Telescan Medical Systems 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.

K924187INSTANT MEMORY 2000K883358TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CMK871587THE TELESCAN C.A.R.E. SYSTEMK820276TELESCAN T-30

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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