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)

PEDIATRIC MULTI-FUNCTION ELECTRODES

K-Number: K915159 · 1992-02-07

ApplicantZmi Corp.
Decision Date1992-02-07
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC MULTI-FUNCTION ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Zmi Corp.. It received FDA 510(k) clearance on 1992-02-07 under 510(k) number K915159. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC MULTI-FUNCTION ELECTRODES?

PEDIATRIC MULTI-FUNCTION ELECTRODES is a medical device that received FDA 510(k) clearance on 1992-02-07. The listed applicant is Zmi Corp.. The 510(k) number is K915159.

When did PEDIATRIC MULTI-FUNCTION ELECTRODES receive FDA 510(k) clearance?

PEDIATRIC MULTI-FUNCTION ELECTRODES received FDA 510(k) clearance on 1992-02-07, under 510(k) number K915159.

Who is the listed applicant for PEDIATRIC MULTI-FUNCTION ELECTRODES?

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

What is the FDA product code for PEDIATRIC MULTI-FUNCTION ELECTRODES?

The FDA product code for PEDIATRIC MULTI-FUNCTION ELECTRODES is DRF.

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 Zmi Corp. 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.

K915100BRINDLEY & SMITH ET-1000K913484ZOLL D-900 DEFIBRILLATORK911956ZOLL PD-1400 PACER/DEFIBRILLATORK895032ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODESK885166ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODESK873402ZOLL NTP-1200 PACER/DEFIBRILLATOR

View all 8 devices →

Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, 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.

↑