The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rad-67 Pulse Co-oximeter And Accessories.
| Device ID | K182887 |
| 510k Number | K182887 |
| Device Name: | Masimo Rad-67 Pulse CO-Oximeter 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 | 2018-10-15 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997012812 | K182887 | 000 |
| 00843997008983 | K182887 | 000 |
| 00843997008976 | K182887 | 000 |
| 00843997008853 | K182887 | 000 |
| 00843997008990 | K182887 | 000 |