The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Bsm-2100a Configured Patient Monitor.
| Device ID | K914092 |
| 510k Number | K914092 |
| Device Name: | BSM-2100A CONFIGURED PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-12 |
| Decision Date | 1992-05-28 |