The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Model 9600, Avant Pulse Oximeter.
| Device ID | K023044 |
| 510k Number | K023044 |
| Device Name: | MODEL 9600, AVANT PULSE OXIMETER |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-12 |
| Decision Date | 2003-07-23 |
| Summary: | summary |