| Device Classification Name |
Plethysmograph, Impedance
|
| 510(k) Number |
K852238 |
| Device Name |
IPG-300 |
| Applicant |
| Thornton Associates, Inc. |
| 1001 Twenty-Second St., NW |
|
Washington,
DC
20037
|
|
| Applicant Contact |
THOMAS M SUSMAN |
| Correspondent |
| Thornton Associates, Inc. |
| 1001 Twenty-Second St., NW |
|
Washington,
DC
20037
|
|
| Correspondent Contact |
THOMAS M SUSMAN |
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Date Received | 05/23/1985 |
| Decision Date | 10/11/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|