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FDA 510(k)

ZOLL R SERIES BLS DEFIBRILLATOR

K-Number: K081828 · 2008-12-09

ApplicantZOLL Medical Corporation
Decision Date2008-12-09
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL R SERIES BLS DEFIBRILLATOR 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 2008-12-09 under 510(k) number K081828. 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 BLS DEFIBRILLATOR?

ZOLL R SERIES BLS DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 2008-12-09. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K081828.

When did ZOLL R SERIES BLS DEFIBRILLATOR receive FDA 510(k) clearance?

ZOLL R SERIES BLS DEFIBRILLATOR received FDA 510(k) clearance on 2008-12-09, under 510(k) number K081828.

Who is the listed applicant for ZOLL R SERIES BLS DEFIBRILLATOR?

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 R SERIES BLS DEFIBRILLATOR?

The FDA product code for ZOLL R SERIES BLS DEFIBRILLATOR is MKJ. This falls under the Dental category.

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Other records listing ZOLL Medical Corporation as applicant

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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.

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