The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Org-9200a.
| Device ID | K002068 |
| 510k Number | K002068 |
| Device Name: | ORG-9200A |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-07 |
| Decision Date | 2001-02-08 |