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.
| Device ID | K872793 |
| 510k Number | K872793 |
| Device Name: | DP-700 NIKMAN DEFIB-PADS |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | NIKOMED U.S.A., INC. HILLSBORO BUSINESS CENTER ILENE COURT - BUILDING 8 Belle Mead, NJ 08502 |
| Contact | Donald C Epstein |
| Correspondent | Donald C Epstein NIKOMED U.S.A., INC. HILLSBORO BUSINESS CENTER ILENE COURT - BUILDING 8 Belle Mead, NJ 08502 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-14 |
| Decision Date | 1987-10-09 |