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FDA 510(k)

PACEMAKER FUNCTION ANALYZER

K-Number: K870909 · 1987-04-27

ApplicantPaceart, Inc.
Decision Date1987-04-27
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEMAKER FUNCTION ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Paceart, Inc.. It received FDA 510(k) clearance on 1987-04-27 under 510(k) number K870909. The device is classified under product code KRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACEMAKER FUNCTION ANALYZER?

PACEMAKER FUNCTION ANALYZER is a medical device that received FDA 510(k) clearance on 1987-04-27. The listed applicant is Paceart, Inc.. The 510(k) number is K870909.

When did PACEMAKER FUNCTION ANALYZER receive FDA 510(k) clearance?

PACEMAKER FUNCTION ANALYZER received FDA 510(k) clearance on 1987-04-27, under 510(k) number K870909.

Who is the listed applicant for PACEMAKER FUNCTION ANALYZER?

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 PACEMAKER FUNCTION ANALYZER?

The FDA product code for PACEMAKER FUNCTION ANALYZER is KRE.

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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 CARDIOVOICEK931296PACEART CARDIOPHONE

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Related Devices (Code: KRE)

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.

K110693PACEART OPTIMA SYSTEM SOFTWAREMedtronic, Inc.K072950CYGNUS 12 LEAD ECG MODULECygnus, LLCK032926EKG SPEAKSMedtronic VascularK922742HPM 40 HEART PACEMAKER MONITORBiotronik, GmbH & Co.K915632PACEART CPTS-86/12Paceart, Inc.K895535PACEVIEWMicromedical

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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