The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Acoustic Respiration Sensors, Infant And Neonate.
| Device ID | K173976 |
| 510k Number | K173976 |
| Device Name: | Masimo Acoustic Respiration Sensors, Infant And Neonate |
| Classification | Monitor, Breathing Frequency |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Karina Simpson |
| Correspondent | Sindura Penubarthi Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-09-05 |