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FDA 510(k)

ES 1500 ECG DEMODULATOR

K-Number: K921699 · 1992-12-17

ApplicantEpic Systems, Inc.
Decision Date1992-12-17
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ES 1500 ECG DEMODULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Epic Systems, Inc.. It received FDA 510(k) clearance on 1992-12-17 under 510(k) number K921699. 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 ES 1500 ECG DEMODULATOR?

ES 1500 ECG DEMODULATOR is a medical device that received FDA 510(k) clearance on 1992-12-17. The listed applicant is Epic Systems, Inc.. The 510(k) number is K921699.

When did ES 1500 ECG DEMODULATOR receive FDA 510(k) clearance?

ES 1500 ECG DEMODULATOR received FDA 510(k) clearance on 1992-12-17, under 510(k) number K921699.

Who is the listed applicant for ES 1500 ECG DEMODULATOR?

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

What is the FDA product code for ES 1500 ECG DEMODULATOR?

The FDA product code for ES 1500 ECG DEMODULATOR 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 Epic Systems, Inc. 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.

K922783ES1700 ECG MODULATORK912281ES1600 PARAMEDIC TELEPHONE

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

View on FDA Database →

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

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