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FDA 510(k)

MODEL 4222 AMBULATORY ECG MONITOR

K-Number: K904250 · 1991-02-25

ApplicantByrncrest Global, Inc.
Decision Date1991-02-25
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 4222 AMBULATORY ECG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Byrncrest Global, Inc.. It received FDA 510(k) clearance on 1991-02-25 under 510(k) number K904250. 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 MODEL 4222 AMBULATORY ECG MONITOR?

MODEL 4222 AMBULATORY ECG MONITOR is a medical device that received FDA 510(k) clearance on 1991-02-25. The listed applicant is Byrncrest Global, Inc.. The 510(k) number is K904250.

When did MODEL 4222 AMBULATORY ECG MONITOR receive FDA 510(k) clearance?

MODEL 4222 AMBULATORY ECG MONITOR received FDA 510(k) clearance on 1991-02-25, under 510(k) number K904250.

Who is the listed applicant for MODEL 4222 AMBULATORY ECG MONITOR?

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

What is the FDA product code for MODEL 4222 AMBULATORY ECG MONITOR?

The FDA product code for MODEL 4222 AMBULATORY ECG MONITOR is DXH. This falls under the Hematology category.

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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.

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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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