The following data is part of a premarket notification filed by Covidien, Formerly Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Oximax N-600x Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside Spo2 Patien.
| Device ID | K123581 |
| 510k Number | K123581 |
| Device Name: | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN |
| Classification | Oximeter |
| Applicant | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Mia M Ware |
| Correspondent | Mia M Ware COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. 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 | 2012-11-20 |
| Decision Date | 2013-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521582583 | K123581 | 000 |
| 10884521181229 | K123581 | 000 |
| 10884521582606 | K123581 | 000 |
| 10884521211148 | K123581 | 000 |
| 10884521096776 | K123581 | 000 |
| 10884521181236 | K123581 | 000 |