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)

ZOLL EPCR IOS

K-Number: K131919 · 2013-12-17

ApplicantZOLL Medical Corporation
Decision Date2013-12-17
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL EPCR IOS 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 2013-12-17 under 510(k) number K131919. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLL EPCR IOS?

ZOLL EPCR IOS is a medical device that received FDA 510(k) clearance on 2013-12-17. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K131919.

When did ZOLL EPCR IOS receive FDA 510(k) clearance?

ZOLL EPCR IOS received FDA 510(k) clearance on 2013-12-17, under 510(k) number K131919.

Who is the listed applicant for ZOLL EPCR IOS?

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 ZOLL EPCR IOS?

The FDA product code for ZOLL EPCR IOS is DXJ.

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: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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.

↑