The following data is part of a premarket notification filed by Bioview Ltd. with the FDA for Modification To Duet System.
| Device ID | K050840 |
| 510k Number | K050840 |
| Device Name: | MODIFICATION TO DUET SYSTEM |
| Classification | Device, Automated Cell-locating |
| Applicant | BIOVIEW LTD. 11 MENACHEM BEGIN ST. Ramat-gan, IL 52521 |
| Contact | Dorit Winitz |
| Correspondent | Dorit Winitz BIOVIEW LTD. 11 MENACHEM BEGIN ST. Ramat-gan, IL 52521 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2005-08-16 |
| Summary: | summary |