The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Masimo Set Radical Pulse Oximeter With Satshare And Masimo Series Of Sensors And Cables.
| Device ID | K012992 |
| 510k Number | K012992 |
| Device Name: | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-06 |
| Decision Date | 2001-10-03 |
| Summary: | summary |