Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K120880 |
Device Name |
ORBIT |
Applicant |
NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC |
6901 E. Fish Lake Road |
Suite 188 |
Maple Grove,
MN
55369
|
|
Applicant Contact |
MARY KAY JENSEN |
Correspondent |
NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC |
6901 E. Fish Lake Road |
Suite 188 |
Maple Grove,
MN
55369
|
|
Correspondent Contact |
MARY KAY JENSEN |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 03/23/2012 |
Decision Date | 04/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|