Device Classification Name |
ventilator, emergency, powered (resuscitator)
|
510(k) Number |
K973975 |
Device Name |
RESPIRTECHPRO |
Applicant |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
3941 J ST., SUITE 354 |
SACRAMENTO,
CA
95819
|
|
Applicant Contact |
GORDON A WONG |
Correspondent |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
3941 J ST., SUITE 354 |
SACRAMENTO,
CA
95819
|
|
Correspondent Contact |
GORDON A WONG |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 10/20/1997 |
Decision Date | 06/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|