The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rad-97 And Accessories.
| Device ID | K183697 |
| 510k Number | K183697 |
| Device Name: | Masimo Rad-97 And Accessories |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Sindura Penubarthi |
| Correspondent | Sindura Penubarthi Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997014687 | K183697 | 000 |
| 00843997002950 | K183697 | 000 |
| 00843997003032 | K183697 | 000 |
| 00843997016797 | K183697 | 000 |
| 00843997014694 | K183697 | 000 |
| 00843997014700 | K183697 | 000 |
| 00843997014779 | K183697 | 000 |
| 00843997014786 | K183697 | 000 |
| 00843997014830 | K183697 | 000 |
| 00843997014663 | K183697 | 000 |
| 00843997017442 | K183697 | 000 |