Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K953411 |
Device Name |
BREATH-TAKER BREATH-ALERT |
Applicant |
ROXON - UNIVERSAL MEDICAL LTD. |
141, EAST - COLUMBIA ST. |
NEW WESTMINISTER, B.C.,
CA
V3L 3V9
|
|
Applicant Contact |
MO SHARIFF |
Correspondent |
ROXON - UNIVERSAL MEDICAL LTD. |
141, EAST - COLUMBIA ST. |
NEW WESTMINISTER, B.C.,
CA
V3L 3V9
|
|
Correspondent Contact |
MO SHARIFF |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 07/20/1995 |
Decision Date | 06/13/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|