Device Classification Name |
Resuscitator, Manual, Non Self-Inflating
|
510(k) Number |
K970785 |
Device Name |
SIMS HYPERINFLATION BAG SYSTEM |
Applicant |
SIMS |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Applicant Contact |
AVIA TONEY |
Correspondent |
SIMS |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Correspondent Contact |
AVIA TONEY |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/04/1997 |
Decision Date | 06/13/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|