The following data is part of a premarket notification filed by Biop Medical Ltd. with the FDA for Biop Digital Colposcope.
| Device ID | K182764 |
| 510k Number | K182764 |
| Device Name: | Biop Digital Colposcope |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | Biop Medical Ltd. 10 O'haliav Street Ramat-gan, IL 5252263 |
| Contact | Ilan Landesman |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street Philadelphia, PA 19103 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2018-11-27 |
| Summary: | summary |