Device Classification Name |
Mask, Oxygen
|
510(k) Number |
K852623 |
Device Name |
OXY-ONE |
Applicant |
ASHAI CO. LTD. |
620 HARRIS ST. |
ULTIMO, N.S.W. 2007 |
AUSTRALIA,
AU
|
|
Applicant Contact |
KALNIN |
Correspondent |
ASHAI CO. LTD. |
620 HARRIS ST. |
ULTIMO, N.S.W. 2007 |
AUSTRALIA,
AU
|
|
Correspondent Contact |
KALNIN |
Regulation Number | 868.5580
|
Classification Product Code |
|
Date Received | 06/20/1985 |
Decision Date | 09/18/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|