The following data is part of a premarket notification filed by Oxitone Medical Ltd. with the FDA for Oxitone 1000.
| Device ID | K163382 |
| 510k Number | K163382 |
| Device Name: | Oxitone 1000 |
| Classification | Oximeter |
| Applicant | Oxitone Medical Ltd. 17 Atir Yeda Street Kfar Saba, IL 4464312 |
| Contact | Leon Eisen |
| Correspondent | Paul Dryden ProMedic, LLC 24301 Woodsage Dr. Bonita Springs, FL 34134 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-01 |
| Decision Date | 2017-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017350004 | K163382 | 000 |