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FDA 510(k)

PACEMAKER SYS ANALYZER #384

K-Number: K833647 · 1983-12-16

ApplicantPacesetter Systems
Decision Date1983-12-16
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACEMAKER SYS ANALYZER #384 is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1983-12-16 under 510(k) number K833647. 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 SYS ANALYZER #384?

PACEMAKER SYS ANALYZER #384 is a medical device that received FDA 510(k) clearance on 1983-12-16. The listed applicant is Pacesetter Systems. The 510(k) number is K833647.

When did PACEMAKER SYS ANALYZER #384 receive FDA 510(k) clearance?

PACEMAKER SYS ANALYZER #384 received FDA 510(k) clearance on 1983-12-16, under 510(k) number K833647.

Who is the listed applicant for PACEMAKER SYS ANALYZER #384?

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

What is the FDA product code for PACEMAKER SYS ANALYZER #384?

The FDA product code for PACEMAKER SYS ANALYZER #384 is KRE.

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Other records listing Pacesetter Systems as applicant

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K910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONEK902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028TK900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERSK900550FAST-PASS ACE MODELS 1212T/1222T/1216T/1226TK895447ENDOCARDIAL SCREW-IN LEAD MODEL 1020TK891905CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

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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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