The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model Avant 2120 Pulse Oximeter And Nibp.
| Device ID | K031487 |
| 510k Number | K031487 |
| Device Name: | MODEL AVANT 2120 PULSE OXIMETER AND NIBP |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Contact | Richard P Bennett |
| Correspondent | Richard P Bennett NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-12 |
| Decision Date | 2004-03-22 |
| Summary: | summary |