K101031 is an FDA 510(k) clearance for the MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on November 18, 2010, 219 days after receiving the submission on April 13, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K101031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2010 |
| Decision Date | November 18, 2010 |
| Days to Decision | 219 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |