The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ecg Monitor Oscilloscope Model Oec-3100.
| Device ID | K800005 |
| 510k Number | K800005 |
| Device Name: | ECG MONITOR OSCILLOSCOPE MODEL OEC-3100 |
| Classification | Electrocardiograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-02 |
| Decision Date | 1980-03-05 |