FDA.reportPublic FDA data

510(k) K203231

Device
Switched Internal Paddles
Applicant
Philips North America, LLC
510(k) number
K203231
Product code
LDD
Decision
Substantially Equivalent (SESE)
Decision date
2021-01-11
Date received
2020-11-02
Regulation
870.5300
Classification name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neha Hardiya
Address
22100 Bothell Everett Hwy. Bothell WA US 98021 98021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K081574ZOLL R SERIESZOLL Medical Corporation2008-09-18
K042302ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLEZoll Medical Corp2004-10-26
K032691ZOLL AUTOCLAVABLE INTERNAL HANDLESZoll Medical Corp2003-11-13
K030417DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLESPhilips Medical Systems2003-05-09