The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Carescape Spo2 – Masimo With Sphb.
| Device ID | K221953 |
| 510k Number | K221953 |
| Device Name: | Masimo CARESCAPE SpO2 – Masimo With SpHb |
| Classification | Oximeter |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Unji Lee |
| Correspondent | Unji Lee Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997010818 | K221953 | 000 |