510(k) K872793
K872793 is an FDA 510(k) premarket notification submitted by Nikomed U.S.A., Inc. for the device "DP-700 NIKMAN DEFIB-PADS". The FDA issued a decision of Substantially Equivalent on October 9, 1987. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Nikomed U.S.A., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1987
- Date Received
- July 14, 1987
- 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