Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K041664 |
Device Name |
PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C |
Applicant |
ON SITE GAS SYSTEMS, INC. |
35 BUDNEY RD. |
BUDNEY INDUSTRIAL PARK |
NEWINGTON,,
CT
06111
|
|
Applicant Contact |
C. BART GULLONG |
Correspondent |
ON SITE GAS SYSTEMS, INC. |
35 BUDNEY RD. |
BUDNEY INDUSTRIAL PARK |
NEWINGTON,,
CT
06111
|
|
Correspondent Contact |
C. BART GULLONG |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 06/18/2004 |
Decision Date | 07/29/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|