Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ULTRA SOFTWARE MODULE: MODEL 2016

K-Number: K863046 · 1986-12-05

ApplicantCardiac Pacemakers, Inc.
Decision Date1986-12-05
Product CodeKRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRA SOFTWARE MODULE: MODEL 2016 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 1986-12-05 under 510(k) number K863046. 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 ULTRA SOFTWARE MODULE: MODEL 2016?

ULTRA SOFTWARE MODULE: MODEL 2016 is a medical device that received FDA 510(k) clearance on 1986-12-05. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K863046.

When did ULTRA SOFTWARE MODULE: MODEL 2016 receive FDA 510(k) clearance?

ULTRA SOFTWARE MODULE: MODEL 2016 received FDA 510(k) clearance on 1986-12-05, under 510(k) number K863046.

Who is the listed applicant for ULTRA SOFTWARE MODULE: MODEL 2016?

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 ULTRA SOFTWARE MODULE: MODEL 2016?

The FDA product code for ULTRA SOFTWARE MODULE: MODEL 2016 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 76 devices →

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.

↑