The following data is part of a premarket notification filed by Diagnostic Devices Pty Ltd with the FDA for Heartevent, Model At.
| Device ID | K072385 |
| 510k Number | K072385 |
| Device Name: | HEARTEVENT, MODEL AT |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | DIAGNOSTIC DEVICES PTY LTD SUITE 405 OFFICE TOWER WESTFIELD EASTGARDENS Eastgardens, AU 2036 |
| Contact | Harry Platt |
| Correspondent | Harry Platt DIAGNOSTIC DEVICES PTY LTD SUITE 405 OFFICE TOWER WESTFIELD EASTGARDENS Eastgardens, AU 2036 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-24 |
| Decision Date | 2008-01-11 |
| Summary: | summary |