The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Masimo Set Intellivue Pulse Oximeter Module.
| Device ID | K040259 |
| 510k Number | K040259 |
| Device Name: | MASIMO SET INTELLIVUE PULSE OXIMETER MODULE |
| 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 | 2004-02-04 |
| Decision Date | 2004-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997012751 | K040259 | 000 |
| 00843997004381 | K040259 | 000 |
| 00843997005821 | K040259 | 000 |
| 00843997006699 | K040259 | 000 |
| 00843997009386 | K040259 | 000 |
| 00843997009393 | K040259 | 000 |
| 00843997009409 | K040259 | 000 |
| 00843997011495 | K040259 | 000 |
| 00843997011501 | K040259 | 000 |
| 00843997011518 | K040259 | 000 |
| 00843997000543 | K040259 | 000 |