FDA 510(k)

Switched Internal Paddles

K-Number: K203231 · 2021-01-11

Decision Date2021-01-11

Product CodeLDD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Switched Internal Paddles is the device name listed in this FDA 510(k) record. The listed applicant is Philips North America, LLC. It received FDA 510(k) clearance on 2021-01-11 under 510(k) number K203231. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Switched Internal Paddles?

Switched Internal Paddles is a medical device that received FDA 510(k) clearance on 2021-01-11. The listed applicant is Philips North America, LLC. The 510(k) number is K203231.

When did Switched Internal Paddles receive FDA 510(k) clearance?

Switched Internal Paddles received FDA 510(k) clearance on 2021-01-11, under 510(k) number K203231.

Who is the listed applicant for Switched Internal Paddles?

The FDA 510(k) record lists Philips North America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Switched Internal Paddles?

The FDA product code for Switched Internal Paddles is LDD.

Related Devices (Code: LDD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.

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.