The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nka Model Sec-3102 Cardiac Stimulator.
| Device ID | K894492 |
| 510k Number | K894492 |
| Device Name: | NKA MODEL SEC-3102 CARDIAC STIMULATOR |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Alex Gerwer |
| Correspondent | Alex Gerwer NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-18 |
| Decision Date | 1989-12-20 |