FDA 510(k)

HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A

K-Number: K021453 · 2002-07-03

Decision Date2002-07-03

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 Philips Medical Systems. It received FDA 510(k) clearance on 2002-07-03 under 510(k) number K021453. 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 2002-07-03. The listed applicant is Philips Medical Systems. The 510(k) number is K021453.

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 2002-07-03, under 510(k) number K021453.

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

The FDA 510(k) record lists Philips Medical Systems 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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Related Devices (Code: MKJ)

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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.