ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE

Dc-defibrillator, Low-energy, (including Paddles)

ZOLL MEDICAL CORP.

The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles With Integrated Electrodes, Zoll Autoclavable.

Pre-market Notification Details

• Device ID: K042302
• 510k Number: K042302
• Device Name: ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
• Classification: Dc-defibrillator, Low-energy, (including Paddles)
• Applicant: ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105
• Contact: Sean Reynolds
• Correspondent: Sean Reynolds; ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford, MA 01824 -4105
• Product Code: LDD
• CFR Regulation Number: 870.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-25
• Decision Date: 2004-10-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00847946022433	K042302	000
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