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FDA 510(k)

HEARTSTREAM FR2 AED, MODEL M3860A,M3861A

K-Number: K003565 · 2000-12-20

ApplicantAgilent Technologies, Inc.
Decision Date2000-12-20
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSTREAM FR2 AED, MODEL M3860A,M3861A 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 2000-12-20 under 510(k) number K003565. 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 FR2 AED, MODEL M3860A,M3861A?

HEARTSTREAM FR2 AED, MODEL M3860A,M3861A is a medical device that received FDA 510(k) clearance on 2000-12-20. The listed applicant is Agilent Technologies, Inc.. The 510(k) number is K003565.

When did HEARTSTREAM FR2 AED, MODEL M3860A,M3861A receive FDA 510(k) clearance?

HEARTSTREAM FR2 AED, MODEL M3860A,M3861A received FDA 510(k) clearance on 2000-12-20, under 510(k) number K003565.

Who is the listed applicant for HEARTSTREAM FR2 AED, MODEL M3860A,M3861A?

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 FR2 AED, MODEL M3860A,M3861A?

The FDA product code for HEARTSTREAM FR2 AED, MODEL M3860A,M3861A 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.

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