PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A

Over-the-counter Automated External Defibrillator

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Heartstart Home Defibrillator, Model M5068a.

Pre-market Notification Details

• Device ID: K040904
• 510k Number: K040904
• Device Name: PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
• Classification: Over-the-counter Automated External Defibrillator
• Applicant: PHILIPS MEDICAL SYSTEMS 2301 5TH AVENUE, SUITE 200 Seattle, WA 98121 -1825
• Contact: Teresa Skarr
• Correspondent: Teresa Skarr; PHILIPS MEDICAL SYSTEMS 2301 5TH AVENUE, SUITE 200 Seattle, WA 98121 -1825
• Product Code: NSA
• CFR Regulation Number: 870.5310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-04-07
• Decision Date: 2004-09-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838076716	K040904	000
00884838050693	K040904	000
00884838049130	K040904	000