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-CHEK PACEMAKER MONITOR

K-Number: K801022 · 1980-06-17

ApplicantPowers Medical Systmes
Decision Date1980-06-17
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRA-CHEK PACEMAKER MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Powers Medical Systmes. It received FDA 510(k) clearance on 1980-06-17 under 510(k) number K801022. 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 ULTRA-CHEK PACEMAKER MONITOR?

ULTRA-CHEK PACEMAKER MONITOR is a medical device that received FDA 510(k) clearance on 1980-06-17. The listed applicant is Powers Medical Systmes. The 510(k) number is K801022.

When did ULTRA-CHEK PACEMAKER MONITOR receive FDA 510(k) clearance?

ULTRA-CHEK PACEMAKER MONITOR received FDA 510(k) clearance on 1980-06-17, under 510(k) number K801022.

Who is the listed applicant for ULTRA-CHEK PACEMAKER MONITOR?

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

What is the FDA product code for ULTRA-CHEK PACEMAKER MONITOR?

The FDA product code for ULTRA-CHEK PACEMAKER MONITOR is KRE.

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 Powers Medical Systmes 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.

K811758ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TRK802779LOAD SENTINEL II, TRANS. ELEC. NERVE

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.

↑