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FDA 510(k)

PACEART CPTS-86/12

K-Number: K915632 · 1992-04-14

ApplicantPaceart, Inc.
Decision Date1992-04-14
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEART CPTS-86/12 is the device name listed in this FDA 510(k) record. The listed applicant is Paceart, Inc.. It received FDA 510(k) clearance on 1992-04-14 under 510(k) number K915632. 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 PACEART CPTS-86/12?

PACEART CPTS-86/12 is a medical device that received FDA 510(k) clearance on 1992-04-14. The listed applicant is Paceart, Inc.. The 510(k) number is K915632.

When did PACEART CPTS-86/12 receive FDA 510(k) clearance?

PACEART CPTS-86/12 received FDA 510(k) clearance on 1992-04-14, under 510(k) number K915632.

Who is the listed applicant for PACEART CPTS-86/12?

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 CPTS-86/12?

The FDA product code for PACEART CPTS-86/12 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.K895535PACEVIEWMicromedicalK870909PACEMAKER FUNCTION ANALYZERPaceart, 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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