K100403 is an FDA 510(k) clearance for the MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7. 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 June 23, 2010, 127 days after receiving the submission on February 16, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K100403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2010 |
| Decision Date | June 23, 2010 |
| Days to Decision | 127 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 |