The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Cardiac Trigger, Model: Ctm300.
| Device ID | K083854 |
| 510k Number | K083854 |
| Device Name: | CARDIAC TRIGGER, MODEL: CTM300 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Dick Listro |
| Correspondent | Dick Listro IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-24 |
| Decision Date | 2009-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816396021419 | K083854 | 000 |
| 00816396021402 | K083854 | 000 |
| 00816396020771 | K083854 | 000 |
| 00816396020764 | K083854 | 000 |
| 00816396020757 | K083854 | 000 |
| 00816396020740 | K083854 | 000 |