| Device Classification Name |
System, Pressure Measurement, Intermittent
|
| 510(k) Number |
K913510 |
| Device Name |
MECHANICAL SHAPE SENSOR |
| Applicant |
| Pin Dot Products, Inc. |
| 6001 Gross Pt. Rd. |
|
Niles,
IL
60648
|
|
| Correspondent |
| Pin Dot Products, Inc. |
| 6001 Gross Pt. Rd. |
|
Niles,
IL
60648
|
|
| Regulation Number | 890.1600 |
| Classification Product Code |
|
| Date Received | 08/07/1991 |
| Decision Date | 09/23/1991 |
| 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
|
|
|