The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 2000 Pulse Oximeter.
| Device ID | K982255 |
| 510k Number | K982255 |
| Device Name: | MODEL 2000 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Dick Listro |
| Correspondent | Dick Listro 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 | 1998-06-26 |
| Decision Date | 1998-10-22 |
| Summary: | summary |