The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Oximax N-600x Pulse Oximeter.
| Device ID | K060576 |
| 510k Number | K060576 |
| Device Name: | NELLCOR OXIMAX N-600X PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Patrick Garvey |
| Correspondent | Patrick Garvey NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-06 |
| Decision Date | 2006-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521159751 | K060576 | 000 |
| 20884521139616 | K060576 | 000 |
| 10884521582453 | K060576 | 000 |
| 10884521582514 | K060576 | 000 |
| 10884521582460 | K060576 | 000 |
| 10884521795327 | K060576 | 000 |
| 20884521139623 | K060576 | 000 |
| 10884521803312 | K060576 | 000 |