The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 700 Patient Monitor.
| Device ID | K882118 |
| 510k Number | K882118 |
| Device Name: | MODEL 700 PATIENT MONITOR |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Brenda E Lundy |
| Correspondent | Brenda E Lundy IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-19 |
| Decision Date | 1988-08-02 |