The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Modification To: Masimo Set Radical Pulse Oximeter With Satshare And Lnop Series Of Sensors And Cables.
| Device ID | K040214 |
| 510k Number | K040214 |
| Device Name: | MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP 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 | 2004-01-30 |
| Decision Date | 2004-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997011990 | K040214 | 000 |
| 00843997011075 | K040214 | 000 |
| 00843997011068 | K040214 | 000 |
| 00843997011051 | K040214 | 000 |
| 00843997011044 | K040214 | 000 |
| 00843997011037 | K040214 | 000 |
| 00843997011020 | K040214 | 000 |
| 00843997011013 | K040214 | 000 |
| 00843997006057 | K040214 | 000 |
| 00843997006040 | K040214 | 000 |
| 00843997011082 | K040214 | 000 |
| 00843997011099 | K040214 | 000 |
| 00843997011945 | K040214 | 000 |
| 00843997011174 | K040214 | 000 |
| 00843997011167 | K040214 | 000 |
| 00843997011150 | K040214 | 000 |
| 00843997011143 | K040214 | 000 |
| 00843997011136 | K040214 | 000 |
| 00843997011129 | K040214 | 000 |
| 00843997011112 | K040214 | 000 |
| 00843997011105 | K040214 | 000 |
| 00843997001588 | K040214 | 000 |