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 |