The following data is part of a premarket notification filed by Aerotel Medical Systems (1998) Ltd. with the FDA for Heart 2006.
| Device ID | K032736 |
| 510k Number | K032736 |
| Device Name: | HEART 2006 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | AEROTEL MEDICAL SYSTEMS (1998) LTD. 377 ROUTE 17 Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers AEROTEL MEDICAL SYSTEMS (1998) LTD. 377 ROUTE 17 Hasbrouck Heights, 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 | 2003-09-04 |
| Decision Date | 2003-10-03 |
| Summary: | summary |