The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Set Rad 57 Cm And M Pulse Co-oximeters.
| Device ID | K053477 |
| 510k Number | K053477 |
| Device Name: | MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | James J Cronin |
| Correspondent | James J Cronin 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 | 2005-12-14 |
| Decision Date | 2006-03-16 |
| Summary: | summary |