Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K881881 |
Device Name |
OXYGENATION CATHETER |
Applicant |
VENTECH HEALTHCARE CORP., INC. |
4295 INTERNATIONAL BLVD. |
NORCROSS,
GA
30093
|
|
Applicant Contact |
JOHN SELLERS |
Correspondent |
VENTECH HEALTHCARE CORP., INC. |
4295 INTERNATIONAL BLVD. |
NORCROSS,
GA
30093
|
|
Correspondent Contact |
JOHN SELLERS |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 05/04/1988 |
Decision Date | 02/17/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|