The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Org-7201 Multiparameter Telemetry Monitor.
| Device ID | K860239 |
| 510k Number | K860239 |
| Device Name: | ORG-7201 MULTIPARAMETER TELEMETRY MONITOR |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Dennis Javens |
| Correspondent | Dennis Javens NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-23 |
| Decision Date | 1986-06-26 |