Device Classification Name |
Cannula, Nasal, Oxygen
|
510(k) Number |
K850066 |
Device Name |
OMNIMED NASAL OXYGEN CANNULA |
Applicant |
OMNI INTL., INC. |
345 TACHEVAH DRIVE #9 |
PALM SPRINGS,
CA
92262
|
|
Applicant Contact |
RAMAN KADEVARI |
Correspondent |
OMNI INTL., INC. |
345 TACHEVAH DRIVE #9 |
PALM SPRINGS,
CA
92262
|
|
Correspondent Contact |
RAMAN KADEVARI |
Regulation Number | 868.5340
|
Classification Product Code |
|
Date Received | 01/08/1985 |
Decision Date | 01/24/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|