The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Oximax Neomax Adhesive Forehead Reflectance Oximetry Sensor.
| Device ID | K051271 |
| 510k Number | K051271 |
| Device Name: | OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR |
| Classification | Oximeter |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | James P Garvey |
| Correspondent | James P 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 | 2005-05-17 |
| Decision Date | 2006-01-10 |
| Summary: | summary |