The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Oxisensor Ii Recycled Sensor And Oximax Recycled Sensor.
| Device ID | K033973 |
| 510k Number | K033973 |
| Device Name: | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR |
| Classification | Oximeter, Reprocessed |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Luanne Ng |
| Correspondent | Luanne Ng NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | NLF |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884522042277 | K033973 | 000 |
| 10884522042185 | K033973 | 000 |
| 10884522040891 | K033973 | 000 |
| 10884522040105 | K033973 | 000 |
| 20884522042045 | K033973 | 000 |