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)

ONESTEP PEDIATRIC MFE'S

K-Number: K110978 · 2011-05-13

ApplicantZOLL Medical Corporation
Decision Date2011-05-13
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ONESTEP PEDIATRIC MFE'S is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K110978. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONESTEP PEDIATRIC MFE'S?

ONESTEP PEDIATRIC MFE'S is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K110978.

When did ONESTEP PEDIATRIC MFE'S receive FDA 510(k) clearance?

ONESTEP PEDIATRIC MFE'S received FDA 510(k) clearance on 2011-05-13, under 510(k) number K110978.

Who is the listed applicant for ONESTEP PEDIATRIC MFE'S?

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

What is the FDA product code for ONESTEP PEDIATRIC MFE'S?

The FDA product code for ONESTEP PEDIATRIC MFE'S is MKJ. This falls under the Dental category.

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 ZOLL Medical Corporation 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.

K233486731 Series VentilatorK202375ZOLL Propaq MK180482ZOLL Propaq MK172653Power InfuserK162832731 Series VentilatorsK170533Model 330 Multifunction Aspirator

View all 26 devices →

Related Devices (Code: MKJ)

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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

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.

↑