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FDA 510(k)

ECG MODULATOR

K-Number: K760563 · 1976-09-10

ApplicantPhysio-Control Corp.
Decision Date1976-09-10
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG MODULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1976-09-10 under 510(k) number K760563. 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 ECG MODULATOR?

ECG MODULATOR is a medical device that received FDA 510(k) clearance on 1976-09-10. The listed applicant is Physio-Control Corp.. The 510(k) number is K760563.

When did ECG MODULATOR receive FDA 510(k) clearance?

ECG MODULATOR received FDA 510(k) clearance on 1976-09-10, under 510(k) number K760563.

Who is the listed applicant for ECG MODULATOR?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG MODULATOR?

The FDA product code for ECG MODULATOR is DXH. This falls under the Hematology category.

Related Clinical Trials

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Other records listing Physio-Control Corp. 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.

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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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