The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Physiological Monitor, Models 101,301,201,202,303a.
| Device ID | K854840 |
| 510k Number | K854840 |
| Device Name: | PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A |
| Classification | Electrocardiograph |
| Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Richard A Mentelos |
| Correspondent | Richard A Mentelos IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-04 |
| Decision Date | 1986-05-07 |