The following data is part of a premarket notification filed by Gkc Manufacturing Pty Ltd. with the FDA for Personal Kinetigraph (pkg) System.
| Device ID | K161717 |
| 510k Number | K161717 |
| Device Name: | Personal Kinetigraph (PKG) System |
| Classification | Transducer, Tremor |
| Applicant | GKC MANUFACTURING PTY LTD. LEVEL 15, 440 COLLINS ST Melbourne, AU 3000 |
| Contact | Brendan Fafiani |
| Correspondent | Marie A. Schroeder QUINTILES 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Product Code | GYD |
| Subsequent Product Code | ISD |
| Subsequent Product Code | NXQ |
| CFR Regulation Number | 882.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-22 |
| Decision Date | 2016-09-20 |
| Summary: | summary |