DP-700 NIKMAN DEFIB-PADS

Dc-defibrillator, Low-energy, (including Paddles)

NIKOMED U.S.A., INC.

The following data is part of a premarket notification filed by Nikomed U.s.a., Inc. with the FDA for Dp-700 Nikman Defib-pads.

Pre-market Notification Details

Device IDK872793
510k NumberK872793
Device Name:DP-700 NIKMAN DEFIB-PADS
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant NIKOMED U.S.A., INC. HILLSBORO BUSINESS CENTER ILENE COURT - BUILDING 8 Belle Mead,  NJ  08502
ContactDonald C Epstein
CorrespondentDonald C Epstein
NIKOMED U.S.A., INC. HILLSBORO BUSINESS CENTER ILENE COURT - BUILDING 8 Belle Mead,  NJ  08502
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-14
Decision Date1987-10-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.