The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Cardiofax Ce, Model Ecg-1500 A.
| Device ID | K052511 |
| 510k Number | K052511 |
| Device Name: | CARDIOFAX CE, MODEL ECG-1500 A |
| Classification | Electrocardiograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Serrah Namini |
| Correspondent | Serrah Namini 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 | 2005-09-14 |
| Decision Date | 2006-05-24 |
| Summary: | summary |