FDA 510(k)

HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR

K-Number: K982025 · 1998-09-04

Decision Date1998-09-04

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1998-09-04 under 510(k) number K982025. 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 HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR?

HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1998-09-04. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K982025.

When did HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR receive FDA 510(k) clearance?

HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR received FDA 510(k) clearance on 1998-09-04, under 510(k) number K982025.

Who is the listed applicant for HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR?

The FDA product code for HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR is MKJ. This falls under the Dental category.

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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.