The following data is part of a premarket notification filed by Covidien with the FDA for N-600x With Spd, Oximax N-600x.
| Device ID | K083325 |
| 510k Number | K083325 |
| Device Name: | N-600X WITH SPD, OXIMAX N-600X |
| Classification | Oximeter |
| Applicant | COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Contact | Scott D Dickerhoff |
| Correspondent | Scott D Dickerhoff COVIDIEN 6135 GUNBARREL AVE. Boulder, CO 80301 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-12 |
| Decision Date | 2009-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521582811 | K083325 | 000 |
| 10884521582828 | K083325 | 000 |