PERSONAL KINETIGRAPH (PKG) SYSTEM
FDA 510(k) clearance K140086 · decided 2014-08-22
Clearance details
- K-number
- K140086
- Device name
- PERSONAL KINETIGRAPH (PKG) SYSTEM
- Applicant
- Gkc Manufacturing Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-14
- Decision date
- 2014-08-22
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- GYD
- Device class
- 2
- Regulation number
- 882.1950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.