The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Lifescope 8 Dec-8108a And Dec-8204a.
| Device ID | K852270 |
| 510k Number | K852270 |
| Device Name: | LIFESCOPE 8 DEC-8108A AND DEC-8204A |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-28 |
| Decision Date | 1985-07-30 |