The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 704.
| Device ID | K912139 |
| 510k Number | K912139 |
| Device Name: | MODEL 704 |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Steven M.simon |
| Correspondent | Steven M.simon IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1992-03-25 |