| Device Classification Name |
Plethysmograph, Pressure
|
| 510(k) Number |
K852088 |
| Device Name |
SYSTEM 1085 BODY PLETHYSMOGRAPH |
| Applicant |
| Medical Graphics Corp. |
| 501 W. County Rd. E |
|
St. Paul,
MN
55112
|
|
| Applicant Contact |
RONALD H BERGESON |
| Correspondent |
| Medical Graphics Corp. |
| 501 W. County Rd. E |
|
St. Paul,
MN
55112
|
|
| Correspondent Contact |
RONALD H BERGESON |
| Regulation Number | 868.1750 |
| Classification Product Code |
|
| Date Received | 05/13/1985 |
| Decision Date | 07/30/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|