510(k) K081574
K081574 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "ZOLL R SERIES". The FDA issued a decision of Substantially Equivalent on September 18, 2008. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. ZOLL Medical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2008
- Date Received
- June 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device Class
- Class II
- Regulation Number
- 870.5300
- Review Panel
- CV
- Submission Type