Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K874567 |
Device Name |
RESUSCITATOR |
Applicant |
AMERICAN MEDICAL TECHNOLOGY, INC. |
C/O VENTURE MGMT CONSULTING |
BOX 160 GRAND VIEW TERRACE EXT |
BROOKLYN,
CT
06234
|
|
Applicant Contact |
GENE ZAMBA |
Correspondent |
AMERICAN MEDICAL TECHNOLOGY, INC. |
C/O VENTURE MGMT CONSULTING |
BOX 160 GRAND VIEW TERRACE EXT |
BROOKLYN,
CT
06234
|
|
Correspondent Contact |
GENE ZAMBA |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 11/05/1987 |
Decision Date | 02/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|