Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K042758 |
Device Name |
POLYTECH PULMONARY FUNCTION FILTER |
Applicant |
POLYTECHNIC RESOURCES, INC. |
1107 MIDDLE RIVER ROAD |
SUITE B-1 |
BALTIMORE,
MD
21220
|
|
Applicant Contact |
TIMOTHY BYRD |
Correspondent |
POLYTECHNIC RESOURCES, INC. |
1107 MIDDLE RIVER ROAD |
SUITE B-1 |
BALTIMORE,
MD
21220
|
|
Correspondent Contact |
TIMOTHY BYRD |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 10/04/2004 |
Decision Date | 08/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|