The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Cardiac Trigger Monitor.
| Device ID | K170828 |
| 510k Number | K170828 |
| Device Name: | Cardiac Trigger Monitor |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 |
| Contact | Nicole Bush |
| Correspondent | Nicole Bush Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 |
| Product Code | DRT |
| Subsequent Product Code | IXO |
| Subsequent Product Code | IYY |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-20 |
| Decision Date | 2017-05-17 |