Device Classification Name |
calculator, predicted values, pulmonary function
|
510(k) Number |
K894667 |
Device Name |
MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP |
Applicant |
PNEUMEDICS, INC. |
291 PEPE'S FRAM RD. |
MILFORD,
CT
06460
|
|
Applicant Contact |
P IMBRUCE |
Correspondent |
PNEUMEDICS, INC. |
291 PEPE'S FRAM RD. |
MILFORD,
CT
06460
|
|
Correspondent Contact |
P IMBRUCE |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 07/25/1989 |
Decision Date | 10/19/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|