The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Anesthesia Monitor; Bedside Monitor, Series Bsm-5130a.
| Device ID | K030105 |
| 510k Number | K030105 |
| Device Name: | ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Serrah Namini |
| Correspondent | Serrah Namini NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-13 |
| Decision Date | 2003-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921859735 | K030105 | 000 |
| 00841983100161 | K030105 | 000 |