Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K880262 |
Device Name |
MOBILE PAK, MODEL DC |
Applicant |
INTL. BIOMEDICAL CONCEPTS, INC. |
2955 SOUTH TEJON |
ENGLEWOOD,
CO
80110
|
|
Applicant Contact |
GEORGI, III |
Correspondent |
INTL. BIOMEDICAL CONCEPTS, INC. |
2955 SOUTH TEJON |
ENGLEWOOD,
CO
80110
|
|
Correspondent Contact |
GEORGI, III |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 01/22/1988 |
Decision Date | 02/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|