![]() | ||||||||||||||||||||||||||||||||||||||||||||||
FDA 510(k) Applications for Medical Device Product Code "GYD"
|
FDA 510(k) Number | Applicant | Device Name | Decision Date |
K971318 | AXON INSTRUMENTS, INC. | MM-1 MOVEMENT MONITOR | 07/28/1997 |
K063872 | CLEVELAND MEDICAL DEVICES, INC. | KINESIA | 04/06/2007 |
K010270 | FLEXABLE SYSTEMS, INC. | TREMOROMETER | 07/25/2001 |
K211887 | GKC Manufacturing Pty Ltd | Personal Kinetigraph (PKG) System Gen 2 Plus | 03/11/2022 |
K140086 | GKC MANUFACTURING PTY LTD. | PERSONAL KINETIGRAPH (PKG) SYSTEM | 08/22/2014 |
K161717 | GKC MANUFACTURING PTY LTD. | Personal Kinetigraph (PKG) System | 09/20/2016 |
K220820 | H2O Bilisim Yazilim | Parky App | 11/17/2022 |
K221772 | New Touch Digital Inc. | NeuroRPM | 03/17/2023 |
K213519 | Rune Labs, Inc. | Rune Labs Tremor Transducer System | 06/10/2022 |
K011429 | TELECOM MEDICAL, INC. | MODEL 100 ACTIVITY MONITOR | 07/13/2001 |