HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)

Automated External Defibrillators (non-wearable)

HEARTSTREAM, INC.

The following data is part of a premarket notification filed by Heartstream, Inc. with the FDA for Heartstramelectrode Adapter(ea-xx Series)/heartstram Defibrillation Pads With Preattached Electrode Adapter(dp-eaxx).

Pre-market Notification Details

• Device ID: K972418
• 510k Number: K972418
• Device Name: HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)
• Classification: Automated External Defibrillators (non-wearable)
• Applicant: HEARTSTREAM, INC. 2401 FOURTH AVE., SUITE 300 Seattle, WA 98121
• Contact: Cindy Pestka
• Correspondent: Cindy Pestka; HEARTSTREAM, INC. 2401 FOURTH AVE., SUITE 300 Seattle, WA 98121
• Product Code: MKJ
• CFR Regulation Number: 870.5310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-27
• Decision Date: 1997-09-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838037984	K972418	000
00884838037960	K972418	000