Device Classification Name |
valve, non-rebreathing
|
510(k) Number |
K870253 |
Device Name |
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR |
Applicant |
INTERTECH RESOURCES, INC. |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Applicant Contact |
JAMES W POPE |
Correspondent |
INTERTECH RESOURCES, INC. |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Correspondent Contact |
JAMES W POPE |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 01/22/1987 |
Decision Date | 03/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|