The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Masimo Set Ms-1 Pulse Oximeter & The Lnop Series Of Sensors & Cables.
| Device ID | K962603 |
| 510k Number | K962603 |
| Device Name: | MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES |
| Classification | Oximeter |
| Applicant | MASIMO CORP. 23361 MADERO ST. SUITE 100 Mission Viejo, CA 92691 |
| Contact | James J Cronin |
| Correspondent | James J Cronin MASIMO CORP. 23361 MADERO ST. SUITE 100 Mission Viejo, CA 92691 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-02 |
| Decision Date | 1997-02-06 |