Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K083879 |
Device Name |
INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) |
Applicant |
INNOVISION A/S |
10 E. SCRANTON AVE. |
SUITE 201 |
LAKE BLUFF,
IL
60044
|
|
Applicant Contact |
H. CARL JENKINS |
Correspondent |
INNOVISION A/S |
10 E. SCRANTON AVE. |
SUITE 201 |
LAKE BLUFF,
IL
60044
|
|
Correspondent Contact |
H. CARL JENKINS |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 12/29/2008 |
Decision Date | 02/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|