The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Patient Safety Net.
| Device ID | K071047 |
| 510k Number | K071047 |
| Device Name: | MASIMO PATIENT SAFETY NET |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-13 |
| Decision Date | 2007-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997012096 | K071047 | 000 |
| 00843997012089 | K071047 | 000 |
| 00843997012072 | K071047 | 000 |
| 00843997012065 | K071047 | 000 |
| 00843997010436 | K071047 | 000 |