POWERCHARGER

Pulse-generator, Pacemaker, External

ZOLL MEDICAL CORP.

The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Powercharger.

Pre-market Notification Details

• Device ID: K934016
• 510k Number: K934016
• Device Name: POWERCHARGER
• Classification: Pulse-generator, Pacemaker, External
• Applicant: ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803
• Contact: Frederick W Faller
• Correspondent: Frederick W Faller; ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803
• Product Code: DTE
• Subsequent Product Code: DRT
• Subsequent Product Code: LDD
• CFR Regulation Number: 870.3600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-08-18
• Decision Date: 1994-10-18