The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Ras-125c Acoustic Respiration Sensor.
| Device ID | K120984 |
| 510k Number | K120984 |
| Device Name: | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | Patricia Milbank |
| Correspondent | Patricia Milbank MASIMO CORPORATION 40 PARKER 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 | 2012-04-02 |
| Decision Date | 2013-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843997009635 | K120984 | 000 |
| 10843997007440 | K120984 | 000 |
| 10843997007426 | K120984 | 000 |
| 10843997007358 | K120984 | 000 |
| 10843997007068 | K120984 | 000 |
| 00843997008938 | K120984 | 000 |
| 00843997008198 | K120984 | 000 |
| 00843997007856 | K120984 | 000 |
| 00843997007849 | K120984 | 000 |