The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Mightysat Rx Fingertip Pulse Oximeter.
| Device ID | K181956 |
| 510k Number | K181956 |
| Device Name: | Masimo MightySat Rx Fingertip Pulse Oximeter |
| Classification | Oximeter |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Kelly Nguyen |
| Correspondent | Sindura Penubarthi Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-23 |
| Decision Date | 2019-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997016551 | K181956 | 000 |
| 00843997016476 | K181956 | 000 |
| 00843997014854 | K181956 | 000 |
| 00843997014465 | K181956 | 000 |
| 00843997014458 | K181956 | 000 |
| 00843997005111 | K181956 | 000 |