The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5v Pulse Oximeter, Model Rad-5v.
| Device ID | K033296 |
| 510k Number | K033296 |
| Device Name: | MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V |
| Classification | Oximeter |
| Applicant | MASIMO CORP. 2852 KELVIN AVE. Irvine, CA 92614 -5826 |
| Contact | James J Cronin |
| Correspondent | James J Cronin MASIMO CORP. 2852 KELVIN AVE. Irvine, CA 92614 -5826 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2004-02-19 |
| Summary: | summary |