| Device Classification Name |
System, Pressure Measurement, Intermittent
|
| 510(k) Number |
K914776 |
| Device Name |
OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR |
| Applicant |
| Talley Group, Ltd. |
| 815 Terminal Rd. |
|
Lansing,
MI
48906
|
|
| Applicant Contact |
VAN DYKE |
| Correspondent |
| Talley Group, Ltd. |
| 815 Terminal Rd. |
|
Lansing,
MI
48906
|
|
| Correspondent Contact |
VAN DYKE |
| Regulation Number | 890.1600 |
| Classification Product Code |
|
| Date Received | 10/23/1991 |
| Decision Date | 12/19/1991 |
| 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
|
|
|