The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Qp-932e Ecg Exercise Test Option For The Nihon Kohden Ecg-9320/a Cardiofax Electrocardiograph.
| Device ID | K972310 |
| 510k Number | K972310 |
| Device Name: | NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Gary Reasoner |
| Correspondent | Gary Reasoner NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-20 |
| Decision Date | 1997-08-20 |
| Summary: | summary |