The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Lifescope 8, Oec-8120 Portable Patient Monitor Rec.
| Device ID | K862463 |
| 510k Number | K862463 |
| Device Name: | LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-30 |
| Decision Date | 1986-12-05 |