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 |