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FDA 510(k)

ELECTRONIC PACEMAKER WAVEFORM ANALYZER

K-Number: K800696 · 1980-08-14

ApplicantInstromedix, Inc.
Decision Date1980-08-14
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC PACEMAKER WAVEFORM ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1980-08-14 under 510(k) number K800696. 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 ELECTRONIC PACEMAKER WAVEFORM ANALYZER?

ELECTRONIC PACEMAKER WAVEFORM ANALYZER is a medical device that received FDA 510(k) clearance on 1980-08-14. The listed applicant is Instromedix, Inc.. The 510(k) number is K800696.

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

ELECTRONIC PACEMAKER WAVEFORM ANALYZER received FDA 510(k) clearance on 1980-08-14, under 510(k) number K800696.

Who is the listed applicant for ELECTRONIC PACEMAKER WAVEFORM ANALYZER?

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

What is the FDA product code for ELECTRONIC PACEMAKER WAVEFORM ANALYZER?

The FDA product code for ELECTRONIC PACEMAKER WAVEFORM ANALYZER is KRE.

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Other records listing Instromedix, 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.

K964408POSEIDON CARDIAC MONITORING SYSTEM (PCMS)K964036CARDIOMAGIC 2000 SOFTWAREK955060ACCELERATED TRANSMISSION PROTOCOLK951096LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVERK945476HEARTHWATCH III(TM)K950003CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS

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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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