| Device Classification Name |
Plethysmograph, Impedance
|
| 510(k) Number |
K822522 |
| Device Name |
CUTANEOUS PRESSURE PLETHYSMOGRAPH |
| Applicant |
| Life Sciences Manufacturing, Inc. |
|
NH
|
|
| Correspondent |
| Life Sciences Manufacturing, Inc. |
|
NH
|
|
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Date Received | 08/23/1982 |
| Decision Date | 09/28/1982 |
| 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
|
|
|