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FDA 510(k)

PACEART CARDIOPHONE

K-Number: K931296 · 1993-10-01

ApplicantPaceart, Inc.
Decision Date1993-10-01
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEART CARDIOPHONE is the device name listed in this FDA 510(k) record. The listed applicant is Paceart, Inc.. It received FDA 510(k) clearance on 1993-10-01 under 510(k) number K931296. 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 CARDIOPHONE?

PACEART CARDIOPHONE is a medical device that received FDA 510(k) clearance on 1993-10-01. The listed applicant is Paceart, Inc.. The 510(k) number is K931296.

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

PACEART CARDIOPHONE received FDA 510(k) clearance on 1993-10-01, under 510(k) number K931296.

Who is the listed applicant for PACEART CARDIOPHONE?

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 CARDIOPHONE?

The FDA product code for PACEART CARDIOPHONE 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 ELECTRODESK952065PACEART CARDIOVOICEK915632PACEART CPTS-86/12

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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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