Device Classification Name |
calculator, predicted values, pulmonary function
|
510(k) Number |
K090722 |
Device Name |
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM |
Applicant |
SHAPE MEDICAL SYSTEMS, INC |
1313 5TH AVE. SE |
SUITE 205 |
MINNEAPOLIS,
MN
55414
|
|
Applicant Contact |
CLARENCE JOHNSON |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 03/19/2009 |
Decision Date | 03/31/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|