Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric
FDA 510(k) K103783 · Fiab Spa
510(k) numberK103783
Submission
- Device name
- Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric
- Applicant
- Fiab Spa
Vicchio Florence, IT - Received
- December 27, 2010
- Decision date
- June 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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Questions and answers
When was Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric cleared by the FDA?
Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads Pediatric (K103783) received a 510(k) decision of Substantially Equivalent on June 16, 2011, 171 days after the submission was received.
What is the product code of K103783?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.