The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Bsm-1101 And Bsm-1102 Patient Monitor And Accessories.
| Device ID | K973918 |
| 510k Number | K973918 |
| Device Name: | NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Gary Reasoner |
| Correspondent | Gary Reasoner NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-15 |
| Decision Date | 1998-01-13 |
| Summary: | summary |