The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Models 706 Ecg/pressure/resp./sao2, 705 Ecg/resp..
| Device ID | K901504 |
| 510k Number | K901504 |
| Device Name: | MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-29 |
| Decision Date | 1990-08-23 |