The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rainbow Set Rad 87 Pulse Co-oximeter And Accessories.
Device ID | K073024 |
510k Number | K073024 |
Device Name: | MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES |
Classification | Oximeter |
Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
Contact | Marguerite Thomlinson |
Correspondent | Marguerite Thomlinson MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-26 |
Decision Date | 2008-02-08 |
Summary: | summary |