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FDA 510(k), K040904, PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
FDA 510(k), K040904, PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
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510(K) Number: K040904
Device Name: PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
Manufacturer: TERESA SKARR
Device Classification Name: Over-The-Counter Automated External Defibrillator
Regulation Number: NSA
Classification Product Code: 04/07/2004
Date Received: 09/16/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
Manufacturer: TERESA SKARR
Device Classification Name: Over-The-Counter Automated External Defibrillator
Regulation Number: NSA
Classification Product Code: 04/07/2004
Date Received: 09/16/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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