The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Physiological Monitor, Models 401,402 & 403.
| Device ID | K862647 |
| 510k Number | K862647 |
| Device Name: | PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 |
| Classification | Computer, Blood-pressure |
| 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 | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-11 |
| Decision Date | 1986-08-18 |