The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Cardimax Model Fx-2111.
| Device ID | K955416 |
| 510k Number | K955416 |
| Device Name: | CARDIMAX MODEL FX-2111 |
| Classification | Electrocardiograph |
| Applicant | FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-27 |
| Decision Date | 1996-07-15 |
| Summary: | summary |