The following data is part of a premarket notification filed by S.l.p. Ltd. with the FDA for Oxsat 100.
| Device ID | K191574 |
| 510k Number | K191574 |
| Device Name: | OxSAT 100 |
| Classification | Oximeter |
| Applicant | S.L.P. Ltd. 62 Anilewicz Street Tel-aviv, IL 67060 |
| Contact | Avi Yosef |
| Correspondent | Paul Dryden S.L.P. Ltd. C/o ProMedic, LLC 131 Bay Point Dr. NE. St Petersburg, FL 67060 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2020-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016715774 | K191574 | 000 |
| 07290016714500 | K191574 | 000 |
| 07290016714487 | K191574 | 000 |
| 07290016714470 | K191574 | 000 |
| 07290016714463 | K191574 | 000 |
| 07290016714456 | K191574 | 000 |
| 07290016714425 | K191574 | 000 |
| 07290016714418 | K191574 | 000 |
| 07290016714364 | K191574 | 000 |
| 07290016714517 | K191574 | 000 |
| 07290016714524 | K191574 | 000 |
| 07290016715231 | K191574 | 000 |
| 07290016715224 | K191574 | 000 |
| 07290016715200 | K191574 | 000 |
| 07290016715156 | K191574 | 000 |
| 07290016714609 | K191574 | 000 |
| 07290016714555 | K191574 | 000 |
| 07290016714548 | K191574 | 000 |
| 07290016714531 | K191574 | 000 |
| 07290016714357 | K191574 | 000 |