The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Physiological Monitor, Model 3000 (series).
| Device ID | K023616 |
| 510k Number | K023616 |
| Device Name: | PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) |
| 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 | 2002-10-29 |
| Decision Date | 2002-11-04 |