The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Cardimax Electrocardiograph.
| Device ID | K173226 |
| 510k Number | K173226 |
| Device Name: | CardiMax Electrocardiograph |
| Classification | Electrocardiograph |
| Applicant | Fukuda Denshi USA, Inc. 17725-C NE 65th St. Redmond, WA 98052 |
| Contact | Doug Blakely |
| Correspondent | Doug Blakely Fukuda Denshi USA, Inc. 17725-C NE 65th St. 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 | 2017-10-03 |
| Decision Date | 2018-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612915130 | K173226 | 000 |
| 04538612915154 | K173226 | 000 |
| 04538612060588 | K173226 | 000 |
| 04538612916038 | K173226 | 000 |
| 04538612916007 | K173226 | 000 |
| 04538612915994 | K173226 | 000 |
| 04538612915970 | K173226 | 000 |
| 04538612915949 | K173226 | 000 |
| 04538612915901 | K173226 | 000 |
| 04538612915765 | K173226 | 000 |
| 04538612915369 | K173226 | 000 |
| 04538612912023 | K173226 | 000 |
| 04538612101106 | K173226 | 000 |
| 04538612101052 | K173226 | 000 |
| 04538612059834 | K173226 | 000 |
| 04538612100802 | K173226 | 000 |
| 04538612060953 | K173226 | 000 |
| 04538612040313 | K173226 | 000 |
| 04538612027109 | K173226 | 000 |
| 04538612026461 | K173226 | 000 |
| 04538612021176 | K173226 | 000 |
| 04538612121234 | K173226 | 000 |
| 04538612230127 | K173226 | 000 |
| 04538612230110 | K173226 | 000 |
| 04538612122576 | K173226 | 000 |
| 04538612101021 | K173226 | 000 |
| 04538612914553 | K173226 | 000 |
| 04538612100994 | K173226 | 000 |
| 04538612100963 | K173226 | 000 |
| 04538612058523 | K173226 | 000 |