The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Qp-156e Ecg Exercise Test Option For The Ecg-1500a Series/cardiofax V.
| Device ID | K072060 |
| 510k Number | K072060 |
| Device Name: | QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V |
| Classification | Electrocardiograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Jack Coggan |
| Correspondent | Jack Coggan 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-27 |
| Decision Date | 2007-08-17 |
| Summary: | summary |