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Heartstreamfr2 Aed With M3848a And M3849a (M3860a +3 more)

FDA 510(k)

Class III (US FDA 510(k))

510(k) K014157

by Philips Medical Systems

Identifiers

510(k) Number
K014157 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)
Models / Variants
M3860a FDA 510(k)
M3861 FDA 510(k)
M3840a FDA 510(k)
M3841a FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
ST FDA 510(k)

The Heartstream FR2 AED with M3848A and M3849A is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts and visual guidance to first responders, enabling non-medical personnel to administer defibrillation safely and effectively in out-of-hospital settings. The device incorporates advanced algorithms to analyze heart rhythms and determine when defibrillation is required. Models M3860A, M3861, M3840A, and M3841A are included in this classification, each adhering to the same core functionality and regulatory standards.

This device is intended for single-use or reusable applications, depending on the specific model configuration, and is classified under FDA product code MKJ as a Class III medical device. It requires FDA 510(k) clearance and has been designated as Substantially Equivalent – Subject to Tracking. The Heartstream FR2 AED is supplied with accessories M3848A and M3849A, which may include pads or other components necessary for operation. Storage and handling follow standard protocols for defibrillators, ensuring proper functionality and sterility where applicable. The device is regulated under 21 CFR 870.5310 and is intended for emergency cardiac care in prehospital and public-access environments.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Heartstreamfr2 Aed With M3848a and M3849a, Models M3860a, M3861, M3840a ..., 510(k) Premarket Notification - Food and Drug Administration, K014157 FDA 510(k) - HEARTSTREAMFR2 AED WITH M3848A AND M3849A, Heartstreamfr2 Aed With M3848a and M3849a, Models M3860a, M3861, M3840a ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems

Sources (1)

  • FDA 510(k) K014157 24 fields · synced Sep 20, 2026