The following data is part of a premarket notification filed by Aerotel Medical Systems (1998) Ltd. with the FDA for Heart 2005.
| Device ID | K000775 |
| 510k Number | K000775 |
| Device Name: | HEART 2005 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | AEROTEL MEDICAL SYSTEMS (1998) LTD. 377ROUTE 17 S Hasbrouck Height, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers AEROTEL MEDICAL SYSTEMS (1998) LTD. 377ROUTE 17 S Hasbrouck Height, NJ 07604 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-09 |
| Decision Date | 2000-05-17 |