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FDA 510(k)

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM

K-Number: K982090 · 1999-01-26

ApplicantPaceart, Inc.
Decision Date1999-01-26
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Paceart, Inc.. It received FDA 510(k) clearance on 1999-01-26 under 510(k) number K982090. 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 PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM?

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-26. The listed applicant is Paceart, Inc.. The 510(k) number is K982090.

When did PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM receive FDA 510(k) clearance?

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM received FDA 510(k) clearance on 1999-01-26, under 510(k) number K982090.

Who is the listed applicant for PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM?

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

What is the FDA product code for PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM?

The FDA product code for PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM is DXH. This falls under the Hematology category.

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Other records listing Paceart, 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.

K012407PACEART TX3 CARDIAC EVENT RECORDERK973141HEART ACCESS PLUS CARDIAC EVENT RECORDERK960721PACEART WRIST ELECTRODESK952065PACEART CARDIOVOICEK931296PACEART CARDIOPHONEK915632PACEART CPTS-86/12

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Related Devices (Code: DXH)

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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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