| Device Classification Name |
Plethysmograph, Impedance
|
| 510(k) Number |
K903700 |
| Device Name |
IPG-II MODULE |
| Applicant |
| Life Sciences Manufacturing, Inc. |
| Airport Industrial Park |
| Box 37f |
|
West Lebanon,
NH
03784
|
|
| Applicant Contact |
ROBERT S CUTLER |
| Correspondent |
| Life Sciences Manufacturing, Inc. |
| Airport Industrial Park |
| Box 37f |
|
West Lebanon,
NH
03784
|
|
| Correspondent Contact |
ROBERT S CUTLER |
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Date Received | 08/15/1990 |
| Decision Date | 01/16/1991 |
| 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
|
|
|