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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B675WR190 | K172735 | 000 |
B675DRYFLEXM2 | K172735 | 000 |
B675DRYFLEXT2 | K172735 | 000 |
B675SILVERFLATSOFTS1 | K172735 | 000 |
B675SILVERFLEXSOFTM1 | K172735 | 000 |
B675SILVERFLEXSOFTS1 | K172735 | 000 |
B675SILVERFLEXSOFTT1 | K172735 | 000 |
B675SOFTFLATS1 | K172735 | 000 |
B675SOFTFLATT2 | K172735 | 000 |
B675SOFTFLEXM1 | K172735 | 000 |
B675SOFTFLEXS1 | K172735 | 000 |
B675SOFTFLEXT1 | K172735 | 000 |
B675DRYFLATS02 | K172735 | 000 |