The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Set Uspo2 Pulse Oximetry Cable.
| Device ID | K121914 |
| 510k Number | K121914 |
| Device Name: | MASIMO SET USPO2 PULSE OXIMETRY CABLE |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | David Collette |
| Correspondent | David Collette MASIMO CORPORATION 40 PARKER 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 | 2012-07-02 |
| Decision Date | 2012-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843997009253 | K121914 | 000 |
| 10843997007679 | K121914 | 000 |
| 10843997007662 | K121914 | 000 |
| 00843997016063 | K121914 | 000 |
| 00843997015998 | K121914 | 000 |
| 00843997012676 | K121914 | 000 |
| 00843997012638 | K121914 | 000 |
| 00843997008853 | K121914 | 000 |