The following data is part of a premarket notification filed by Zeto, Inc. with the FDA for Wr19 System.
| Device ID | K172735 |
| 510k Number | K172735 |
| Device Name: | WR19 System |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | Zeto, Inc. 2336 Park Ave Santa Clara, CA 95050 |
| Contact | Aswin Gunasekar |
| Correspondent | Donna-bea Tillman Biologics Consulting Group 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-11 |
| Decision Date | 2018-04-17 |
| Summary: | summary |