The following data is part of a premarket notification filed by Mobileodt Ltd. with the FDA for Eva (enhanced Visual Assessment) System.
| Device ID | K161871 |
| 510k Number | K161871 |
| Device Name: | EVA (Enhanced Visual Assessment) System |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | MobileODT Ltd. 41 Gershon Shatz St., 2nd Floor Tel Aviv, IL 6701779 |
| Contact | Jen Acobas |
| Correspondent | Jen Acobas MobileODT Ltd. Ben Avigdor 8 3rd Floor Tel Aviv, IL 6721832 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-07 |
| Decision Date | 2016-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290016976547 | K161871 | 000 |
| 17290016976011 | K161871 | 000 |
| 17290016976004 | K161871 | 000 |