The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Lifescope Ii.
| Device ID | K841499 |
| 510k Number | K841499 |
| Device Name: | LIFESCOPE II |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-10 |
| Decision Date | 1984-08-28 |