The following data is part of a premarket notification filed by Masimo Corporation with the FDA for E1 Ear Sensors.
| Device ID | K121912 |
| 510k Number | K121912 |
| Device Name: | E1 EAR SENSORS |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | David Collette |
| Correspondent | David Collette MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2012-07-24 |
| Summary: | summary |