The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Set Radical 7 Pulse Co-oximeter.
| Device ID | K061204 |
| 510k Number | K061204 |
| Device Name: | MASIMO SET RADICAL 7 PULSE CO-OXIMETER |
| 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 |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | JKS |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-01 |
| Decision Date | 2006-07-27 |
| Summary: | summary |