The following data is part of a premarket notification filed by Philips Respironics, Inc with the FDA for Oximetry Interface Kit.
| Device ID | K111378 |
| 510k Number | K111378 |
| Device Name: | OXIMETRY INTERFACE KIT |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | PHILIPS RESPIRONICS, INC 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Elaine Larkin |
| Correspondent | Elaine Larkin PHILIPS RESPIRONICS, INC 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-17 |
| Decision Date | 2011-10-04 |
| Summary: | summary |