The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Lifescope Ii/four.
| Device ID | K823249 |
| 510k Number | K823249 |
| Device Name: | LIFESCOPE II/FOUR |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-01 |
| Decision Date | 1982-11-24 |