The following data is part of a premarket notification filed by Orsense Ltd with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK190322 |
| 510k Number | BK190322 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| Classification | Hemoglobin For Donor Testing |
| Applicant | OrSense Ltd 17 Hamegalsim St Petah Tikva, 4900302, IS |
| Product Code | QGU |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-12 |
| Decision Date | 2019-05-09 |