The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Oximax Pulse Oximetry Sensons (max-a, Max-al, Max-n, Max-i, Max-p.
| Device ID | K052186 |
| 510k Number | K052186 |
| Device Name: | NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2005-11-10 |
| Summary: | summary |