The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Bedside Monitors, Bsm-8301a, Bsm-8302a.
| Device ID | K894692 |
| 510k Number | K894692 |
| Device Name: | BEDSIDE MONITORS, BSM-8301A, BSM-8302A |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Mike Dashefsky |
| Correspondent | Mike Dashefsky 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 | 1989-07-24 |
| Decision Date | 1989-10-02 |