The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Masimo Set Radical Pulse Oximeter, Lnop-adt, Lnop-pdt, Lnop-neo, Lnop-neo Pt, Lnop-dci, Patient Cable (pc04, Pc08, Pc12).
| Device ID | K992238 |
| 510k Number | K992238 |
| Device Name: | MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12) |
| 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 | 1999-07-02 |
| Decision Date | 1999-10-08 |
| Summary: | summary |