The following data is part of a premarket notification filed by Maxx Digm, Inc. with the FDA for Zmaxx T Series.
| Device ID | K161219 |
| 510k Number | K161219 |
| Device Name: | Zmaxx T Series |
| Classification | Powder, Porcelain |
| Applicant | Maxx Digm, Inc. 3265 Kifer Road Santa Clara, CA 95051 |
| Contact | Keith Jew |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, CA 92620 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-29 |
| Decision Date | 2017-01-26 |
| Summary: | summary |