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FDA 510(k)

PACEART CARDIOVOICE

K-Number: K952065 · 1996-01-16

ApplicantPaceart, Inc.
Decision Date1996-01-16
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEART CARDIOVOICE is the device name listed in this FDA 510(k) record. The listed applicant is Paceart, Inc.. It received FDA 510(k) clearance on 1996-01-16 under 510(k) number K952065. 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 CARDIOVOICE?

PACEART CARDIOVOICE is a medical device that received FDA 510(k) clearance on 1996-01-16. The listed applicant is Paceart, Inc.. The 510(k) number is K952065.

When did PACEART CARDIOVOICE receive FDA 510(k) clearance?

PACEART CARDIOVOICE received FDA 510(k) clearance on 1996-01-16, under 510(k) number K952065.

Who is the listed applicant for PACEART CARDIOVOICE?

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 CARDIOVOICE?

The FDA product code for PACEART CARDIOVOICE 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 RECORDERK982090PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEMK973141HEART ACCESS PLUS CARDIAC EVENT RECORDERK960721PACEART WRIST ELECTRODESK931296PACEART 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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