The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rad-97 And Accessories.
| Device ID | K180046 |
| 510k Number | K180046 |
| Device Name: | Masimo Rad-97 And Accessories |
| Classification | Oximeter |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Sindura Penubarthi |
| Correspondent | Sindura Penubarthi Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-08 |
| Decision Date | 2018-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843997009666 | K180046 | 000 |
| 00843997009904 | K180046 | 000 |
| 00843997012317 | K180046 | 000 |
| 00843997012775 | K180046 | 000 |
| 00843997012782 | K180046 | 000 |
| 00843997013079 | K180046 | 000 |
| 00843997013857 | K180046 | 000 |
| 00843997013864 | K180046 | 000 |
| 10843997009642 | K180046 | 000 |
| 10843997009659 | K180046 | 000 |
| 00843997009669 | K180046 | 000 |