Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K082478 |
Device Name |
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 |
Applicant |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Applicant Contact |
JOHN SAWYER |
Correspondent |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent Contact |
JOHN SAWYER |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 08/28/2008 |
Decision Date | 03/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|