Device Classification Name |
Device, Vibration Threshold Measurement
|
510(k) Number |
K934368 |
Device Name |
NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 |
Applicant |
NK BIOTECHNICAL ENGINEERING CO. |
10850 OLD COUNTY RD. 15 |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
KAREN GOTFREDSON |
Correspondent |
NK BIOTECHNICAL ENGINEERING CO. |
10850 OLD COUNTY RD. 15 |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
KAREN GOTFREDSON |
Regulation Number | 882.1200
|
Classification Product Code |
|
Date Received | 09/07/1993 |
Decision Date | 08/11/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|