The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Bedside Monitor, Model Opv-1500.
| Device ID | K032749 |
| 510k Number | K032749 |
| Device Name: | BEDSIDE MONITOR, MODEL OPV-1500 |
| Classification | Monitor, Physiological, Patient (without 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 | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-05 |
| Decision Date | 2003-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921865422 | K032749 | 000 |
| 04931921863695 | K032749 | 000 |
| 04931921863671 | K032749 | 000 |
| 00841983102813 | K032749 | 000 |
| 00841983102806 | K032749 | 000 |
| 00841983100604 | K032749 | 000 |