The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Bsm-2300 &bsm6000 With Cgs-9001 Series Communication Gateway, Model Cgs-9001 Series Optional Accessory.
| Device ID | K083271 |
| 510k Number | K083271 |
| Device Name: | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY |
| 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 | 2008-11-06 |
| Decision Date | 2008-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851725007092 | K083271 | 000 |