Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K854062 |
Device Name |
PALL PULMONARY FUNCTION FILTER |
Applicant |
PALL BIOMEDICAL PRODUCTS CO. |
77 CRESCENT BEACH RD. |
GLEN COVE,
NY
11542
|
|
Applicant Contact |
SIDNEY KRAKAUER |
Correspondent |
PALL BIOMEDICAL PRODUCTS CO. |
77 CRESCENT BEACH RD. |
GLEN COVE,
NY
11542
|
|
Correspondent Contact |
SIDNEY KRAKAUER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 10/04/1985 |
Decision Date | 11/07/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|