| Device Classification Name |
System, Pressure Measurement, Intermittent
|
| 510(k) Number |
K882139 |
| Device Name |
2P-QDA FOOT PRESSURE SYSTEMS REAL TIME |
| Applicant |
| Human Performance Technologies, Inc. |
| 12 Technology Dr., Suite 6 |
|
East Setauket,
NY
11733
|
|
| Applicant Contact |
MICHAEL WITOVER |
| Correspondent |
| Human Performance Technologies, Inc. |
| 12 Technology Dr., Suite 6 |
|
East Setauket,
NY
11733
|
|
| Correspondent Contact |
MICHAEL WITOVER |
| Regulation Number | 890.1600 |
| Classification Product Code |
|
| Date Received | 05/23/1988 |
| Decision Date | 06/22/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|