Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K980951 |
Device Name |
ONEFLOW |
Applicant |
STI MEDICAL |
908 POMPTON AVE. |
CEDAR GROVE,
NJ
07009
|
|
Applicant Contact |
LAUREN R ZIEGLER |
Correspondent |
STI MEDICAL |
908 POMPTON AVE. |
CEDAR GROVE,
NJ
07009
|
|
Correspondent Contact |
LAUREN R ZIEGLER |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 03/13/1998 |
Decision Date | 02/25/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|