The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Disposable Oximetry Ear Sensor, Model E1.
| Device ID | K101031 |
| 510k Number | K101031 |
| Device Name: | MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Product Code | DQA |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DSA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-13 |
| Decision Date | 2010-11-18 |
| Summary: | summary |