The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 702 Ecg/respiration/temperature.
| Device ID | K884455 |
| 510k Number | K884455 |
| Device Name: | MODEL 702 ECG/RESPIRATION/TEMPERATURE |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-24 |
| Decision Date | 1989-03-09 |