The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Bedside Monitor, Bsm 9100a Series.
| Device ID | K082785 |
| 510k Number | K082785 |
| Device Name: | NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Jack Coggan |
| Correspondent | Jack Coggan 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2008-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921899403 | K082785 | 000 |
| 00841983101816 | K082785 | 000 |
| 00841983101823 | K082785 | 000 |
| 00841983101830 | K082785 | 000 |
| 00841983101847 | K082785 | 000 |
| 00841983103391 | K082785 | 000 |
| 00841983103414 | K082785 | 000 |
| 04931921102831 | K082785 | 000 |
| 04931921899373 | K082785 | 000 |
| 04931921899380 | K082785 | 000 |
| 04931921899397 | K082785 | 000 |
| 00841983100543 | K082785 | 000 |