The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Life Scope P, Model Bsm-4100 Series.
| Device ID | K001693 |
| 510k Number | K001693 |
| Device Name: | LIFE SCOPE P, MODEL BSM-4100 SERIES |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-02 |
| Decision Date | 2000-10-24 |