FDA 510(k)

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)

K-Number: K990762 · 1999-09-03

Decision Date1999-09-03

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) 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 1999-09-03 under 510(k) number K990762. 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 - Subject to Tracking Reg..

Frequently Asked Questions

What is the ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)?

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Zoll Medical Corp. The 510(k) number is K990762.

When did ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) receive FDA 510(k) clearance?

ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) received FDA 510(k) clearance on 1999-09-03, under 510(k) number K990762.

Who is the listed applicant for ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)?

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 M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)?

The FDA product code for ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) is MKJ. This falls under the Dental category.

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Other records listing Zoll Medical Corp as applicant

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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.