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 | K140086 |
| 510k Number | K140086 |
| Device Name: | PERSONAL KINETIGRAPH (PKG) SYSTEM |
| Classification | Transducer, Tremor |
| Applicant | GKC MANUFACTURING PTY LTD. 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Contact | Marie Schroeder |
| Correspondent | Marie Schroeder GKC MANUFACTURING PTY LTD. 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 | 2014-01-14 |
| Decision Date | 2014-08-22 |
| Summary: | summary |