The following data is part of a premarket notification filed by Ivy Biomedical Systems Inc. with the FDA for Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor.
| Device ID | K151781 |
| 510k Number | K151781 |
| Device Name: | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE Branford, CT 06405 |
| Contact | Dick Listro |
| Correspondent | Dick Listro IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE Branford, CT 06405 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-01 |
| Decision Date | 2016-05-27 |