The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Multiple Patient Receiver, Model Org-9700a.
| Device ID | K071058 |
| 510k Number | K071058 |
| Device Name: | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| 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 | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-06-29 |
| Summary: | summary |