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FDA 510(k)

SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN

K-Number: K860584 · 1986-06-06

ApplicantCardiac Pacemakers, Inc.
Decision Date1986-06-06
Product CodeKRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1986-06-06 under 510(k) number K860584. The device is classified under product code KRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN?

SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN is a medical device that received FDA 510(k) clearance on 1986-06-06. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K860584.

When did SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN receive FDA 510(k) clearance?

SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN received FDA 510(k) clearance on 1986-06-06, under 510(k) number K860584.

Who is the listed applicant for SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN?

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

What is the FDA product code for SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN?

The FDA product code for SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN is KRG.

Related Clinical Trials

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.

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Other records listing Cardiac Pacemakers, 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.

K093969ACUITY BREAK-AWAY GUIDE CATHETERK080154ACUITY UNIVERSAL CUTTERK934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELERK920601ASTRA T2, ASTRA T4, ASTRA T6K912379PDT CARRYALL TRANSMITTER, VARIOUS MODELSK905674LEAD STYLET

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Related Devices (Code: KRG)

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.

K933278INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04Intermedics, Inc.K884522MODEL 5650 OPTIMATE PERSONAL PROGRAMMERTeletronics, Inc.K880738MODEL 2331T PATIENT PROGRAMMERMedtronic VascularK882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004Tpl-Cordis, Inc.K864712MODEL 1740 PERSONAL POCKET PROGRAMMERTelectronics, Inc.K871986MODEL 5600B PROGRAMMER, PACEMAKERTelectronics, 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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