The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Tec-8251a Defibrillator Monitor, Modification.
| Device ID | K914971 |
| 510k Number | K914971 |
| Device Name: | TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Hayim Zadaca |
| Correspondent | Hayim Zadaca NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1991-12-04 |