FDA 510(k)

HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A

K-Number: K001725 · 2000-09-08

Decision Date2000-09-08

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies, Inc.. It received FDA 510(k) clearance on 2000-09-08 under 510(k) number K001725. 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 HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A?

HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A is a medical device that received FDA 510(k) clearance on 2000-09-08. The listed applicant is Agilent Technologies, Inc.. The 510(k) number is K001725.

When did HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A receive FDA 510(k) clearance?

HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A received FDA 510(k) clearance on 2000-09-08, under 510(k) number K001725.

Who is the listed applicant for HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A?

The FDA 510(k) record lists Agilent Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A?

The FDA product code for HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A is MKJ. This falls under the Dental category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.