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 R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES

K-Number: K090989 · 2009-09-23

ApplicantZoll Medical Corp
Decision Date2009-09-23
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Medical Corp. It received FDA 510(k) clearance on 2009-09-23 under 510(k) number K090989. 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 ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES?

ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES is a medical device that received FDA 510(k) clearance on 2009-09-23. The listed applicant is Zoll Medical Corp. The 510(k) number is K090989.

When did ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES receive FDA 510(k) clearance?

ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES received FDA 510(k) clearance on 2009-09-23, under 510(k) number K090989.

Who is the listed applicant for ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES?

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

What is the FDA product code for ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES?

The FDA product code for ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES 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 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.

K112660POCKETCPRK042007ZOLL E SERIES DEFIBRILLATORK042302ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLEK042417ZOLL M SERIES ETC02 LOFLO OPTIONK033474ZOLL AED PLUSK032691ZOLL AUTOCLAVABLE INTERNAL HANDLES

View all 32 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.

↑