The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Modification To Avant 9600 Pulse Oximeter.
| Device ID | K040589 |
| 510k Number | K040589 |
| Device Name: | MODIFICATION TO AVANT 9600 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Contact | John R Dalpee |
| Correspondent | John R Dalpee NONIN MEDICAL, INC. 2605 FERNBROOK LANE, NORTH Minneapolis, MN 55447 -4755 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166001365 | K040589 | 000 |
| 00833166001372 | K040589 | 000 |